- 1. Are LOGIQ e X and LOGIQ e S separate devices in the 2026 clearance?
- 2. What did K260398 change on the device named LOGIQ e?
- 3. Which transducers and software features does the summary add?
- 4. Can catalog TX64 5436388 or battery 5451284-2 be ordered from the badge?
- 5. Where does a legacy LOGIQ e symptom ticket still go?
- 6. Where Rongtao fits
- 7. Frequently asked questions
Are LOGIQ e X and LOGIQ e S separate devices in the 2026 clearance?
Read the badge, the release, and the clearance as three different documents. On 4 August 2026 GE HealthCare announced the LOGIQ e family, featuring LOGIQ e X and LOGIQ e S, and described them as two compact laptop ultrasound systems. In the same release, footnote i says: "LOGIQ e X and LOGIQ e S are marketing representations of the LOGIQ e product; feature availability may vary depending on region." The release then separates the commercial offer: LOGIQ e X is a premium offering that combines AI-powered tools, advanced imaging capabilities, and workflow-enhancing features, while LOGIQ e S provides essential imaging capabilities in an intuitive, reliable system at a more affordable price point. Each of those names carries footnote i. The family sentence lists multi-purpose imaging, musculoskeletal, emergency medicine, critical care, rheumatology, and anesthesiology as clinical applications of the family. 4
The release also says the latest LOGIQ e ultrasound systems are 510(k) cleared and CE Marked. It does not print a 510(k) number. Trade reports the same day, including AuntMinnie and Medical Economics, repeat the announcement. They are one chain with the release, so they do not add a hardware source. A US search result for the product name on 26 September 2026 included a Henry Schein listing titled Logiq e X H8046EX. That title is a distributor code. It was not used here as a board specification. 4 6 7
K260398 is the clearance that matches the date of this launch. The letter is dated 26 May 2026. The submission was dated and received 6 February 2026. The summary inside the same PDF is dated 4 May 2026. The trade name on the letter and in the summary is LOGIQ e. The applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha. The manufacturer named in the summary is GE Medical Systems (China) Co., Ltd., Wuxi. The letter's regulation number is 21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System, Class II, with product codes IYN, IYO, and ITX. The summary then maps those codes: IYN to 21 CFR 892.1550, IYO to 21 CFR 892.1560 (Ultrasonic Pulsed Echo Imaging System), and ITX to 21 CFR 892.1570 (Diagnostic Ultrasound Transducer). The primary predicate is K232186, also named LOGIQ e. The summary says the proposed LOGIQ e employs the same fundamental scientific technology as its predicate and is substantially equivalent to the predicate devices, and then it lists the differences. Substantial equivalence is a clearance determination. It is not a field-replaceable-unit table. 1 2
The names LOGIQ e X and LOGIQ e S do not appear in that letter or summary. On 26 September 2026 an openFDA device-name search for LOGIQ e, using the API snapshot last updated 14 September 2026, returned six records. Separate device-name searches for LOGIQ e X and for LOGIQ e S each returned no matches. openFDA warns that its results are unvalidated, so the PDF remains the wording source for K260398. A 22 July 2026 FDA 510(k) extract of 175,559 rows agrees on the identity that the extract can store: one K260398 row, device name LOGIQ e, product code IYN, Traditional, decision date 26 May 2026, substantially equivalent. That extract contains no device-name field with LOGIQ e X or LOGIQ e S. It also does not store the summary's hardware bullets. Table 1 is the name rule. Table 2 is the six-record identity list, not an installed-base count. 1 3
| Question | 4 August 2026 release | K260398 letter and summary | Quote rule |
|---|---|---|---|
| What is the device called? | LOGIQ e X and LOGIQ e S, described as two compact laptop systems, then defined by footnote i as marketing representations of the LOGIQ e product. | Trade name LOGIQ e. The names e X and e S are absent. | Write the badge text the customer used. Identify the cleared device as LOGIQ e under K260398. |
| How do e X and e S differ? | e X is described as the premium configuration. e S is described as the essential configuration at a more affordable price. Feature availability may vary by region. | One device name, with optional configurations inside that device. No e X row and no e S row. | Treat the premium-versus-essential split as commercial wording. It does not identify a board. |
| Which clearance is cited? | "510(k) cleared and CE Marked." No K number is printed. | Traditional K260398, decided 26 May 2026, predicate K232186. | Cite K260398 from the FDA PDF. Do not invent a K number from the release. |
| Are the electronics the same as every earlier LOGIQ e? | Footnote i can be misread that way. The same release also marks some features as available only on LOGIQ e X. | The summary keeps the trade name and then lists CPU, probe-port, CWI, operating-system, transducer, and accessory differences versus K232186. | A shared trade name is the regulatory identity. Order the assembly whose etched label you can read. |
Source: GE HealthCare press release, 4 August 2026, footnote i and the premium-versus-essential paragraph; FDA K260398 letter and summary.
| K number | Decision date | Clearance type | Product code | device_name as returned |
|---|---|---|---|---|
| K260398 | 2026-05-26 | Traditional | IYN | LOGIQ e |
| K232186 | 2023-11-03 | Traditional | IYN | LOGIQ e |
| K151028 | 2015-06-18 | Traditional | IYN | LOGIQ e |
| K133533 | 2014-02-12 | Traditional | IYN | LOGIQ E |
| K113690 | 2011-12-29 | Special | IYN | GE LOGIQ I, LOGIQ E AND VIVID E |
| K072797 | 2007-10-17 | Special | IYO | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND |
Source: openFDA device 510(k) API. Results are unvalidated. The K260398 PDF controls the 2026 narrative. Older submission PDFs were not re-read for this table.
Table 2 is why a shared family name is a weak parts key. The newest record is K260398, and its device name is LOGIQ e. Two older records are grouped compact names, and K133533 is returned as LOGIQ E. The API spelling COMAPACT on K072797 is the string openFDA returned. Grouped naming on those older records is not a license to move a board from one compact to another. The LOGIQ e versus LOGIQ E9 board path already owns that legacy split, including why a LOGIQ e X badge leaves the laptop-versus-cart tree until the label matches. 3 11
What did K260398 change on the device named LOGIQ e?
The summary's device description calls the proposed LOGIQ e a compact console with an LCD and a control panel with a new keyboard. It operates from an integrated battery or an AC/DC power adapter. One battery pack is the standard configuration, and an optional pack is described for longer scanning time. Two optional carts are described. The height-adjustable cart is about 510 mm by 510 mm, with height from 830 mm to 1130 mm, and an optional battery box of a charger plus four battery packs. The simple cart is about 555 mm by 545 mm, at a fixed height of 875 mm, without powered electrical components or functions. Those sentences describe the cleared device. They do not name the keyboard, the battery, or either cart as a service part number. 1
The comparison section is more specific, and it is still not a parts list. Under hardware, the summary prints three bullets: the CPU was updated to Intel I5-125U; a two-probe-port option was added; the CWI board was updated to support Voice Control. Under software, a separate line says the operating system was updated from Windows 10 to Windows 11. The summary does not describe the predicate CPU, the predicate keyboard, or a predicate probe-port count beyond the words "added" and "updated." The keyboard sentence stays in the device description. It is evidence that this console is described with a new keyboard. It is not a GE part number, and it is not a measurement of which earlier keyboard it replaces. 1
Accessories added in the same comparison are Digital Expert Connect, wireless chargers for the Vscan Air CL and Vscan Air SL probes, a WiFi-Bluetooth USB adaptor for wireless connectivity with those probes, the LOGIQ e Simple Cart, compatible OEM biopsy-guide accessories for the L6-12-RS, C2-9-RS, and IC9-RS transducers, and the SONY UP-D899MD printer. Digital Expert Connect is named and not defined in the summary. The environmental brochure later says Verisound Collab is the new product name for Digital Expert Connect, and it marks that tool as unavailable in every region and not for diagnostic use. That footnote renames a commercial tool. It still publishes no board number. The biopsy-guide bullet names three transducers and stops. It is not a needle-guide matching chart, and this page does not build one. 1 5
| Item | Where the summary prints it | Wording in the summary | Service part number |
|---|---|---|---|
| Host CPU | Hardware bullets | CPU was updated to Intel I5-125U | None printed |
| Probe ports | Hardware bullets | Added two-probe-port option | None printed |
| CWI board | Hardware bullets | CWI board was updated to support Voice Control | None printed |
| Operating system | Software section | OS updated from Windows 10 to Windows 11 | None printed |
| Keyboard | Device description | Compact console with LCD, and control panel with new keyboard | None printed |
| Console batteries | Device description | One pack standard, plus an optional pack. Height-adjustable cart may add a charger box and four packs. | None printed |
| Height-adjustable cart | Device description | About 510 mm by 510 mm, height 830 mm to 1130 mm | None printed |
| Simple cart | Device description and accessories | About 555 mm by 545 mm, fixed height 875 mm, no powered electrical components. Accessories: Added LOGIQ e Simple Cart. | None printed |
| Vscan Air wireless link | Accessories | Wireless chargers, and a WiFi-Bluetooth USB adaptor, for Vscan Air CL and Vscan Air SL | None printed |
| Printer | Accessories | Added the SONY UP-D899MD printer | None printed |
| Digital Expert Connect | Accessories | Added Digital Expert Connect. The summary does not define it. | None printed |
| Biopsy guides | Accessories | OEM biopsy-guide accessory compatibility added for L6-12-RS, C2-9-RS, and IC9-RS | None printed |
Source: FDA K260398 summary dated 4 May 2026. Device description, hardware bullets, software operating-system line, and accessories bullets.
The summary also says non-clinical testing covered acoustic output, biocompatibility, cleaning and disinfection, and thermal, electrical, electromagnetic, and mechanical safety. Among the voluntary standards it lists IEC 60601-2-37, Edition 3.0, 2024. No clinical study was required for the substantial-equivalence determination. Those sentences are the clearance record. They are not a return-to-service procedure, and they do not set a pass-fail limit for a depot repair. 1
The chart below counts named items in that comparison section. It is a reading of the bullets, not a score of how much the hardware changed and not a parts catalog. Five added transducer names are counted in the next section. High-Res PDI is counted on its own because the summary places it on an existing probe. Eight software feature names are counted on their own, with the Windows line kept separate because the summary prints it as its own line. The keyboard, the battery counts, and the cart dimensions stay in Table 3 because they are device-description sentences rather than comparison bullets, except for the Simple Cart, which the accessories list also names.
View chart data
| Category | Named items |
|---|---|
| Software features | 8 |
| Accessory names | 6 |
| Added transducer names | 5 |
| Hardware bullets | 3 |
| Windows 10 to 11 line | 1 |
| Mode on an existing probe | 1 |
Counted from the 4 May 2026 summary. Added transducer names: L6-12-RS, IC9-RS, C2-9-RS, Vscan Air CL, and Vscan Air SL. High-Res PDI is a mode on existing probe ML6-15-RS, so it is not one of the five. Software features: B Flow, AFI, SonoBiometry, Voice Control, MyPreset, Fleet Management, Connection Manager, and APP API. Hardware bullets: Intel I5-125U, the two-probe-port option, and the CWI update. Accessory names: Digital Expert Connect, wireless chargers, the WiFi-Bluetooth USB adaptor, the LOGIQ e Simple Cart, OEM biopsy-guide compatibility, and the SONY UP-D899MD printer. None of these bars is a service part number.
Source: FDA K260398 summary, comparison section, read 26 September 2026
The environmental brochure, footer JB39170XX September 2026, is a separate document. It prints system dimensions of 375 x 295 x 47 mm, a quiet-fan figure of 36.3 dB, and power figures of 1.4 W in Off Mode, 1.4 W in Standby with no scan, and 80.5 W in Scan Mode. It says the hardware will keep updating for component lifecycle maintenance, and that LOGIQ e family system parts are eligible for assessment through GE's refurbishment program, where they may be refurbished, harvested, or recycled depending on condition when GE HealthCare takes possession. Those are manufacturer lifecycle statements. They are not a third-party interchange list, and Rongtao does not participate in that program. The watt, size, and noise figures are brochure figures. They are not in the K260398 hardware bullets. 5
Which transducers and software features does the summary add?
The transducer bullets are additions to the device named LOGIQ e, each tied to an earlier clearance. They are not a fleet compatibility matrix, and they do not say that every LOGIQ e console already in service accepts the new probes. L6-12-RS and IC9-RS were previously cleared on Versana Premier (K242005); the summary says their clinical applications and imaging modes are similar to that reference device. C2-9-RS was previously cleared on Venue (K251322). The summary adds Abdominal, Fetal/Obstetrics, and Urology applications that had been cleared on Vivid S70N and Vivid S60N (K223832) with the C2-9-D probe, and it says the C2-9-RS probe is the same as the C2-9-D except that it uses an RS connector instead of a D connector. It also adds Thoracic/Pleural, which it says was already cleared with the curved transducer C1-5-RS on predicate LOGIQ e (K232186). Vscan Air CL and Vscan Air SL were cleared on Vscan Air (K250087), and the summary says they have also been cleared on other consoles such as Venue (K251322). High-Res PDI is added on the existing probe ML6-15-RS; the summary says both that mode and that probe were already cleared on predicate LOGIQ e (K232186). 1
| Name in the summary | What the summary says | Earlier clearance the summary cites | Service part number |
|---|---|---|---|
| L6-12-RS | Added. Applications and imaging modes similar to the reference device. | Versana Premier K242005 | None printed |
| IC9-RS | Added. Applications and imaging modes similar to the reference device. | Versana Premier K242005 | None printed |
| C2-9-RS | Added. Same as C2-9-D except an RS connector instead of a D connector. Abdominal, Fetal/Obstetrics, and Urology applications cited from the C2-9-D on Vivid S70N and Vivid S60N. Thoracic/Pleural cited from C1-5-RS on predicate LOGIQ e. | Venue K251322; applications also cite K223832 and K232186 | None printed |
| Vscan Air CL and Vscan Air SL | Added. Applications and imaging modes similar to the reference device. Also cleared on other consoles such as Venue. | Vscan Air K250087; also cites Venue K251322 | None printed |
| ML6-15-RS | Existing probe. High-Res PDI imaging mode added. The summary says both the mode and the probe were already cleared on the predicate. | Predicate LOGIQ e K232186 | None printed |
Source: FDA K260398 summary, transducer bullets. No service part numbers are printed.
The brochure uses probe names the summary does not add. It attaches L4-20t-RS to a LOGIQ e X high-frequency superficial MSK line, and it also lists L4-20t-RS, C2-9-RS, and M5Sc-RS together under a LOGIQ e line with XDclear. It mentions control buttons on the L4-20t-RS and L4-12t-RS probes, and it says the family has up to 16 types of probe selection. C2-9-RS is the name that also appears in K260398. L4-20t-RS, L4-12t-RS, and M5Sc-RS do not appear in the K260398 transducer bullets. The "up to 16" sentence is brochure wording, not a clearance count. Keep those names on the brochure side of the file. 1 5
The release and the summary also disagree in useful ways about software, which is another reason a feature list is not a board list. The summary's software bullets are in Table 5. The release describes B-Flow, Speckle Reduction Imaging (SRI)-HD, AFI, SonoBiometry, Voice Control, Scan Assistant, Nerveblox, MSK Go, Verisound Fleet, and Verisound Collab. Scan Assistant, Nerveblox, MSK Go, and SRI-HD are not K260398 software bullets. Footnote iii of the release reads "Only available on LOGIQ e X," and in the release HTML that marker sits on "AI-powered features," on Scan Assistant, and on AFI. The summary's AFI sentence is different: it is a tool for global and regional assessment of systolic function of the left ventricle, right ventricle, and left atrium, using feature tracking on 2D grey-scale loops, similar to AFI on Vivid iq (K200278). The summary never says AFI is limited to a marketing name the summary does not use. Voice Control is both a software bullet and the stated reason for the CWI board update. The release places Vscan Air probe compatibility on LOGIQ e X under footnote i, while the summary adds Vscan Air CL and Vscan Air SL to the device named LOGIQ e. None of those sentences identifies the USB adaptor's part number. 1 4
| Feature | Summary's wording | Reference the summary cites |
|---|---|---|
| B Flow | Intended to provide a more intuitive representation of non-quantitative hemodynamics in vascular structures. Same as the reference device. | Versana Premier K242005 |
| AFI | Global and regional assessment of systolic function of the left ventricle, right ventricle, and left atrium, from feature tracking on 2D grey-scale loops. Similar to the reference device. | Vivid iq K200278 |
| SonoBiometry | An alternative to common fetal biometry measurements. Same as the reference device. | Versana Premier K242005 |
| Voice Control | Lets users activate certain functions by speaking recognized commands. Similar to the reference device. The hardware section says the CWI board was updated to support it. | LOGIQ Totus K232381 |
| MyPreset | Lets users customize and save frequently used scanning presets. Same as the reference device. | Versana Premier K242005 |
| Fleet Management | Remote device management for cloud preset configuration, backup, and restore. Same as the reference device. | LOGIQ E10s K251963 |
| Connection Manager | A wizard through Network, Remote devices, Print Flow, Dataflow, and Local devices. Similar to the reference device. | LOGIQ E10s K251963 |
| APP API | A standardized interface for integrating software components. Same as the reference device. | Venue K251322 |
| Operating system | Updated from Windows 10 to Windows 11. No software image and no install procedure are printed. | Printed as its own line, without a reference K number |
Source: FDA K260398 summary, software features and the operating-system line. "Same as" and "similar to" follow the summary's words.
The summary says the system supports electronic delivery of software, and that the user, in addition to service personnel, can update software by logging into a GE HealthCare website. Download from that website requires an account. This page stops at that sentence. It does not publish the account, download, or install steps. The brochure separately names eDelivery and InSite as GE remote-service channels. Those names belong to the manufacturer workflow. They are not a method for copying a Windows image from one console onto another, and the K260398 operating-system line is not a field-upgrade instruction for an earlier LOGIQ e. Fleet Windows support dates live on the legacy ultrasound cybersecurity page, which this article does not copy. 1 5
Can catalog TX64 5436388 or battery 5451284-2 be ordered from the badge?
Only when the etched label matches. Rongtao's photographed catalog records for this family, reviewed 26 September 2026, are TX64 5436388 on model LOGIQ E and battery 5451284-2 on model LOGIQ E(R7). On that date the catalog availability line for a photographed part without a matched stock row is "Confirm with Rongtao support." K260398 does not print either number. It also does not print a replacement number for the transmit board, the keyboard, the CPU board, the CWI board, or the battery. The empty cell means the badge is not enough. It does not mean a technician can declare the photographed part incompatible from the badge either. Match the etch, including the revision the label actually shows. 1 8
| Etched label | What the catalog photograph shows | What K260398 prints | When it can be quoted |
|---|---|---|---|
| 5436388 | TX64, model LOGIQ E. Photograph record. Availability is confirmed with support, not promised from this page. | No transmit-board part number. | When the removed board's etched label matches 5436388. The 13 September LOGIQ e page owns the legacy laptop-versus-E9 use of this label. |
| 5451284-2 | Battery, model LOGIQ E(R7). Photograph record. Same availability rule. | A standard pack, an optional pack, and a cart box of four packs. No battery part number. | When the pack label matches 5451284-2. The portable battery page owns pack-versus-adapter-versus-DC-board triage after that match. |
Source: Rongtao catalog photographs for logiq-e-tx64-5436388 and logiq-e-r7-battery-5451284-2. K260398 prints neither number.
Marketplace listings mix other LOGIQ e transmit and battery strings into the same search. That identity split is already written on the LOGIQ e versus LOGIQ E9 page. This page does not rebuild it. Use that page when the etch matches a legacy laptop label. Stop on this page when the badge says e X or e S and the etch does not match a label you have verified. 11
Where does a legacy LOGIQ e symptom ticket still go?
After the label matches a legacy laptop LOGIQ e assembly, the symptom routes stay on the pages that already own them. K260398 does not replace those routes, and a 2026 badge does not enter them early.
- No image, with a matched TX64 label: use the LOGIQ e versus LOGIQ E9 board path for catalog 5436388 and the laptop-versus-cart split. 11
- Runs on the adapter and dies on battery, with a matched pack label: use the portable battery, charger, and DC-board path. K260398's four-pack cart box is not automatically catalog 5451284-2.
- Dead keys or a dead trackpad, with the image still live: use the control-panel and touch-display path. The "new keyboard" sentence is a configuration fact. It does not skip the label photo.
- Fans run and the console stays on the startup screen: use the storage-versus-motherboard boot path after the host label is known. The Windows 11 line does not identify the failed part.
Where Rongtao fits
Rongtao repairs and supplies tested ultrasound boards after the etched label is matched. For a label-matched LOGIQ e assembly, published service terms are a standard board-repair turnaround of 5 to 8 business days from intake to sign-off, with complex multi-board cases allowed to run longer after the test report stage, a 48-hour run inside an actual ultrasound system before release, and a typical 90-day warranty whose terms are confirmed by product category and service type. A catalog photograph is not current stock. 9 10
Rongtao is an independent service and parts shop. It is not GE HealthCare, it is not an authorized GE representative, and it does not take part in the refurbishment program described in brochure JB39170XX. It does not quote a board from a LOGIQ e X or LOGIQ e S badge alone, it does not publish GE software-install steps, and it does not ask a reader to open an energized console, defeat a safety control, or return a system to clinical use without qualified testing. 5
Send the quote packet through the contact form. The process page and the quality page are the service terms behind the turnaround and the 48-hour test.
- A photo of the console rating plate: model, REF, serial number, and manufacturing date, plus the badge text if it says LOGIQ e X or LOGIQ e S.
- A photo of the system information screen: software revision and installed applications.
- Photos of both sides of the removed board or battery, and a close photo of the etched part number, revision, and serial label.
- The symptom or error text, the quantity, and the destination country.
What would change this page: a later 510(k) that uses LOGIQ e X or LOGIQ e S as a trade name, a GE service bulletin that prints part numbers for the keyboard, CPU, CWI board, or battery in this configuration, or a photographed catalog label for one of those assemblies. Until then the quote rule stays on the etch.
Frequently asked questions
Is the LOGIQ e X a new ultrasound platform or a LOGIQ e configuration?
In the 4 August 2026 release, LOGIQ e X and LOGIQ e S are marketing representations of the LOGIQ e product, and feature availability may vary by region. In K260398 the cleared trade name is LOGIQ e. The summary still lists hardware and software differences against K232186, so the marketing name is not a statement that every internal assembly is unchanged.
What is FDA K260398?
K260398 is a Traditional 510(k) decided on 26 May 2026 for GE Medical Systems Ultrasound and Primary Care Diagnostics. It clears the LOGIQ e ultrasound system, with the letter citing 21 CFR 892.1550 and product codes IYN, IYO, and ITX, as substantially equivalent to predicate K232186. The summary is dated 4 May 2026 and contains the change list used on this page.
Did the 2026 LOGIQ e clearance change the keyboard or the CPU?
The hardware bullets say the CPU was updated to Intel I5-125U. The device description says the control panel has a new keyboard. The hardware bullets also say the CWI board was updated to support Voice Control, and the software section says the operating system moved from Windows 10 to Windows 11. The summary prints no service part number for the CPU, the keyboard, or the CWI board.
Does a LOGIQ e X badge mean catalog TX64 5436388 still fits?
The badge does not answer that. K260398 does not mention 5436388, and it does not publish a different transmit-board number. Quote 5436388 when the etched label on the removed board matches it. The same rule applies to battery 5451284-2.
Are LOGIQ e X and LOGIQ e S different boards from each other?
K260398 does not distinguish them. The release describes e X as the premium configuration and e S as the essential configuration, under a footnote that both names represent the LOGIQ e product. Optional hardware in the summary, such as the two-probe-port option, can differ from unit to unit. The etched label is how you tell which assembly is installed.
Can an older LOGIQ e be moved to Windows 11 from the K260398 software line?
The summary records the operating-system change on the cleared device, together with the CPU update to Intel I5-125U. It does not describe a field upgrade for an earlier console. This page does not publish install steps. Use the official path that matches the console generation you can identify from the rating plate and the host label.
