Vivid Explorer, Advanced, and Focus Are Not E95 Boards

Which differences among Explorer, Advanced, and Focus are actually written in K261313?

On 28 August 2026, GE HealthCare announced Vivid Explorer, Vivid Advanced, and Vivid Focus as three additions to the Vivid cardiovascular portfolio. On 2 September 2026, FDA issued clearance letter K261313 for those three trade names in one submission. A parts buyer still has to separate what the summary actually writes down: three mobile consoles, a common user interface, different displays, and different indication boundaries. The summary does not publish a console board part number, so none of those sentences is a license to order a Vivid E95, S70, T8, or Vivid i board. ^{1 3}

The letter and summary name the submitter as GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, Waukesha, Wisconsin, and the manufacturer as GE Vingmed Ultrasound AS, Horten, Norway. The letter classifies the device under 21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System, Class II, with product codes IYN, IYO, ITX, and QIH. The summary names IYO as an ultrasonic pulsed echo imaging system under 21 CFR 892.1560, ITX as a diagnostic ultrasound transducer under 21 CFR 892.1570, and QIH as a medical image management and processing system under 21 CFR 892.2050. openFDA records the same K number as Traditional, decision code SESE. FDA cleared Vivid Explorer, Vivid Advanced, and Vivid Focus under this one 510(k), not under three filings. ^{1 2 7}

The summary does not describe three completely identical systems with cosmetic badge changes. Instead, it defines explicit clinical indication boundaries and functional divergences across the three trade names: ¹

• Vivid Explorer: The indications comparison says its indications for use are identical to primary predicate Vivid S70N (K223832). The intended-use section includes 3D/4D imaging mode. The device description includes a real-time 3D transducer and says the system can be used with compatible 2D and 4D ICE transducers. The environment list includes the EP lab.
• Vivid Advanced: The indications comparison says its indications are similar to Vivid S70N except that Vivid Advanced does not support 3D/4D imaging modes. The intended-use application list still includes intracardiac, intraluminal, and EP-lab use. The device description nevertheless says it includes real-time 3D transducers with multi-plane imaging, and it names compatible 2D ICE transducers rather than 2D and 4D ICE transducers.
• Vivid Focus: The indications comparison says Focus is not intended for use in the EP lab, does not support intracardiac or intraluminal applications, and does not support 3D/4D imaging modes. The same comparison says Focus indications are identical to reference device Vivid T9 (K243628). The intended-use environment list names the operating room and catheterization lab and does not name the EP lab.

The device description also separates the displays without turning that difference into a board number. Explorer is equipped with either a 23.8-inch HDU display or an optional 23.8-inch LCD. Advanced includes a 23.8-inch LCD. Focus includes a 21.5-inch LCD or an optional 23.8-inch LCD. All three are described as mobile consoles on four wheels, with a common user interface and a 15.6-inch touch panel. A display size is still not a power-supply or beamformer part number. ¹

Read the Advanced sentences beside each other. The device description says Vivid Advanced includes real-time 3D transducers with multi-plane imaging. The indications comparison says Vivid Advanced does not support 3D/4D imaging modes, and the intended-use mode list for Advanced does not include a 3D/4D imaging mode. The summary does not say whether that exclusion is a missing board, a license, or a configuration. Do not order a 3D/4D probe or a 3D processing board from the device-description sentence. The software-feature list later in the same summary is written for the combined submission and includes 4D tools. Those bullets do not put 3D/4D modes back onto Advanced or Focus. ¹

Why does a Vivid S70N predicate not make an E95 or S70 board the right part?

Substantial equivalence is not a circuit-board cross-reference. The K261313 summary says a common cSound foundation across the Vivid portfolio supports consistent imaging, with higher-end systems scaling. That sentence explains why a buyer might treat Explorer as an E95. It does not name a front-end board, a power supply, or a backplane, and it does not make a catalog E95 part fit. ¹

The summary's primary predicate is Vivid S70N/S60N, K223832. openFDA records that submission as Vivid S60N, Vivid S70N, decision date 16 February 2023, Traditional, substantially equivalent, product code IYN. K170823, K181685, and K200743 appear only in the reference-device list, each named Vivid E95. Reference status in this summary is not a statement that an E95 chassis or board installs in Explorer, Advanced, or Focus. ^{1 4}

The letter says FDA determined the device is substantially equivalent for the indications in the enclosure, and that the applicant may market it subject to the general controls. That finding does not identify a printed-circuit assembly. The Vivid S60/S70 report already separates S5/S6, S60/S70, and S60N/S70N, and it says N-series hardware revisions must not be assumed backwards-compatible with early S60/S70 software builds. Use that page for those carts. Do not copy its part numbers onto Explorer, Advanced, or Focus, and do not treat the K223832 predicate as an order for an S70 or S70N board. ^{1 4}

The Vivid E9 and E95 board report owns the E9 versus E80/E90/E95 catalog rows. K261313 lists K170823, K181685, and K200743 only as reference devices. The public catalog does contain E9 and E95 board rows. Those rows stay on that report. This summary does not show that any of them fits Explorer, Advanced, or Focus, and it does not describe these three systems as a compact version of the E95 card cage. ¹

A matching indications sentence is not a chassis order. The summary says Vivid Focus indications are identical to Vivid T9, K243628. That does not make the LOGIQ F6/F8 and Vivid T8 power supply, or any other part on the LOGIQ F and Vivid T8 report, a Focus part. K251169, Vivid Pioneer, is a reference device for the 9VT-D and 6Sc-D indication statements. The Vivid i report already keeps Pioneer outside the published model line. The K261313 summary also says these consoles have a battery scan mode of up to 60 minutes. That sentence is not the Vivid i battery part number. ^{5 6}

Which probe names does the summary add, and which board numbers does it leave out?

The summary names transducer additions. Each line is an indication comparison, not a connector or board match: ¹

• Explorer and Advanced additions: The summary adds the 9VT-D transducer and the 6Sc-D transducer on both Vivid Explorer and Vivid Advanced, with identical indications for use and identical modes of operation to those transducers on Vivid Pioneer (K251169).
• Focus endocavitary addition: The summary adds the IC9-RS transducer on Vivid Focus, with an identical indication for use and similar modes of operation to Versana Premier (K242005).
• Focus 4Sc-RS addition: The summary adds a new 4Sc-RS transducer on Vivid Focus, with the same indication for use as the 3Sc-RS on predicate Vivid S70N (K223832).
• Focus RS transducer suite: The summary lists 6S-RS, 12S-RS, 9L-RS, 12L-RS, L4-20t-RS, 4C-RS, 8C-RS, C1-5-RS, P2D-RS, and L8-18i-RS on Vivid Focus, with similar indications and modes of operation to Vivid T9 (K243628).

These transducer lines are indication statements. The summary does not provide connector pinouts, harnesses, or transceiver-board part numbers, and a -D or -RS suffix in a probe name is not, by itself, a console connector-board order. The accessories list names an ICE RS-DLP Adapter and a Crystal ICE Cord-RS without assigning either one to a console board. The summary also contains no patient-weight limit for the 9VT-D. A seller page that adds a weight cutoff is not this filing. Probe application limits belong in the manufacturer's instructions for use. ¹

The same summary does not list an internal console circuit-board part number, a power-supply part number, or a field-replaceable-unit code for Explorer, Advanced, or Focus. A claim that K261313 proves a catalog board fits one of those trade names is not supported by this record. ¹

One sentence in the non-clinical section names the wrong system. It says: "The proposed Vivid Pioneer complies with voluntary standards," and then lists those standards. The title, device description, and conclusion of the same filing name Vivid Explorer, Vivid Advanced, and Vivid Focus. Vivid Pioneer is reference device K251169, decision date 10 July 2025. Leave the Pioneer sentence as a wrong-name line. It is not a finding that Pioneer hardware is Explorer hardware. ^{1 5}

The standards list that follows the Pioneer sentence includes AAMI/ANSI ES60601-1 (2005/A2:2021) and IEC 60601-2-37 Edition 2.1 (2015). It does not name IEC 60601-1, and it does not name IEC 62353. Those entries are the standards the summary cites for the non-clinical evaluation. They are not a hospital return-to-service protocol and not a depot acceptance test for a replacement board. ¹

How should the 28 August pending footnote be read after the 2 September letter?

The 28 August 2026 GE HealthCare release still carries this footnote: "Vivid Explorer, Vivid Advanced and Vivid Focus are CE Marked and 510(k) pending with the U.S. FDA and not available for sale in the U.S." The 2 September 2026 letter says: "You may, therefore, market the device, subject to the general controls provisions of the Act." Use the letter for United States clearance status. The release page can keep showing the older pending footnote. Neither document is a ship date, a hospital count, or a parts list. ^{1 3}

Understanding how to interpret these two documents across the commercial timeline prevents premature sourcing actions: ^{1 3}

• The letter is the clearance status to use: As of the 2 September 2026 letter, Vivid Explorer, Vivid Advanced, and Vivid Focus are no longer only a pending 510(k). The August release can still display the pending footnote. Quote the letter when the question is whether FDA has cleared the three names.
• Clearance is not a delivery or a parts list: The letter authorizes marketing, subject to the general controls. It is not a ship notice, an installed-base count, or a field-replaceable-unit list.
• CE marking stays on the GE release: The release says the three systems are CE Marked, and a later sentence says the three systems and EchoPAC Software Only v211 have received CE Mark. The FDA letter does not grant or verify that mark.
• EchoPAC v211 is outside K261313: Footnote 3 says EchoPAC Software Only v211 is 510(k) pending and not available for sale in the U.S. Footnote 4 says the EchoPAC functionality described in the release is based on v210 and earlier cleared versions. Do not fold v211 into K261313.

Keep the received dates apart. The FDA 510(k) database page and the openFDA record, last updated 21 September 2026, both show date received 21 April 2026 and decision date 2 September 2026. The PDF letter prints "Dated: July 31, 2026" and "Received: July 31, 2026." The summary header is dated 2 September 2026. Record all three as printed. Do not merge April and July into one received date, and do not explain the gap as an amendment. The clearance date to cite is 2 September 2026. ^{1 2 7}

The letter says FDA's substantial-equivalence determination included review and clearance of a Predetermined Change Control Plan under section 515C of the Act. In the summary, that plan applies exclusively to AI Cardiac Auto Doppler. Modifications under it do not introduce new measurement types, new diagnostic claims, expanded clinical indications, or changes to the clinical interpretation of that feature's results, and they are implemented only through controlled software releases. The plan also allows support for additional cardiac TTE and TEE probes within its own limits. It does not describe a console-board change. A departure that significantly affects safety or effectiveness can still require a new premarket notification, which is the letter's own boundary, not a hardware parts catalog. ¹

What has to be on the label before a Vivid board quote is even possible?

GE has used the Vivid name across portable systems and across E, S, and T consoles. A request that says only "GE Vivid board," "cSound," or "new Vivid" does not identify which of those systems, or whether the nameplate says Explorer, Advanced, or Focus. Do not pick a catalog row from the brand word.

Before a quote, record the facts that distinguish a nameplate from a 510(k) number:

1. Rating-plate trade name: Copy the trade name printed on the console label, such as Vivid Explorer, Vivid Advanced, Vivid Focus, Vivid S70N, or Vivid E95. Explorer on the label is not an instruction to pull an E95 or S70 catalog row.
2. Software string the console displays: Record the software version shown on the system. Do not substitute K261313 for that string. The summary does not give a menu path.
3. Serial number and manufacture date: Copy both from the rating plate. Neither field is a board part number, and the date alone does not prove which K number applies.
4. Photographs: Photograph the rating plate. If a qualified person has already removed a board, photograph both sides of that board, including every etched number and barcode label. Do not open an energized console or reach into a power assembly to take the picture.
5. Fault in the operator's words: Record the symptom or error text as displayed. Note whether it follows one probe or stays with one port. That note is for the quote. It is not a return-to-service test.

The summary says an admin user can securely delete data on the device, including personal information and personal health information, and it compares that feature with Vivid Pioneer. That is a feature sentence. It is not a sanitization procedure for a used-system purchase or a retirement. Acceptance and de-identification for a resale stay in the used-system acceptance and PHI controls. ¹

Where Rongtao fits, and where it does not

Rongtao Medical services and supplies parts for ultrasound systems. Rongtao is not GE HealthCare, not GE Vingmed Ultrasound AS, and not an authorized agent or warranty depot for either company. GE, Voluson, Logiq, and Vivid name the equipment lines. They do not mean Rongtao is the manufacturer.

The published GE model line is Voluson E6/E8/E10, Voluson P6/P8, Voluson S6/S8/S10, Logiq E9/E10/E11, Logiq P5/P6/P7/P9, Logiq S7/S8, Logiq V1/V2/V3/V5, Logiq F6/F8, Vivid E9/E80/E90/E95, Vivid S6/S60/S70, Vivid T8/T9, Vivid I/E, Versana Balance, and Venue 20/40. The coverage note for that line names board families including RFM, RFM423, DBM64, BF64, GTX-TLP, and GRX64/128, plus motherboards, power supplies, and control panels. Those names belong to the published GE model line. They are not Explorer, Advanced, Focus, or Pioneer part numbers.

Vivid Explorer, Vivid Advanced, Vivid Focus, and Vivid Pioneer are outside that published line. On 2 October 2026 the public catalog had 254 SKUs and no model or part-name string for those four names. An empty catalog search is not a claim that no spare part exists anywhere. It means this catalog cannot match a board from the trade name. An E95 or S70 row in the same catalog is not a substitute.

For equipment that is on the published line, Rongtao's Guangzhou technical and warehousing center is 3,000 m², with 35+ senior engineers and service across 140+ countries. Every repaired board runs for 48 hours inside an actual ultrasound system before release. Standard turnaround is 5–8 business days, and the standard warranty is typically 90 days, with the final terms confirmed on the quote. Those figures do not mean an Explorer, Advanced, or Focus board is stocked or repairable.

Quote-ready technical handoff checklist

Send a quote request through contact only after the label facts are in hand. A note that says "Vivid board needed" is not enough.

1. Trade name on the rating plate: The printed name, not the word Vivid.
2. Serial number: The full serial from that plate.
3. Software version: The string the console displays, not K261313.
4. Rating-plate photograph: Model, serial, and electrical ratings legible in one frame.
5. Board-label photographs: Both sides, if a qualified person has already removed the board. Include the etched number and the barcode label.
6. Symptom: The error text or operating symptom in the technician's words, and whether it follows one probe or one port.
7. Quantity and destination: How many, and the destination country.

Frequently asked questions

Did FDA clear three consoles or one filing with three names?
One Traditional 510(k), K261313, covers the three trade names Vivid Explorer, Vivid Advanced, and Vivid Focus under product code IYN, 21 CFR 892.1550. They are not three unrelated submissions. The summary still gives them different indication boundaries, so the single filing is not a finding that the hardware is identical. ^{1 2}

Does the cleared PCCP allow a hardware change without a new 510(k)?
This PCCP does not. It applies exclusively to AI Cardiac Auto Doppler. Modifications under it do not introduce new measurement types, new diagnostic claims, expanded clinical indications, or a change in the clinical interpretation of that feature's results, and they are implemented only through controlled software releases. The summary does not put a console board inside the plan. The letter still says a change that significantly affects safety or effectiveness requires a new premarket notification. ¹

Is EchoPAC Software Only v211 part of K261313?
No. The 28 August 2026 release says EchoPAC Software Only v211 is 510(k) pending and not available for sale in the U.S., and that the EchoPAC function described there is based on v210 and earlier cleared versions. The same release says v211 has received CE Mark. K261313 does not clear it. ³

Can a catalog Vivid E95 panel or a Vivid i battery be ordered for Explorer?
Not from this filing. K261313 names the E95 submissions only as reference devices, and the public catalog's E95 rows are not an Explorer match. The summary's battery-scan sentence, up to 60 minutes, is not the Vivid i battery part number. ¹

Why does the K261313 non-clinical section mention Vivid Pioneer?
The non-clinical section says, "The proposed Vivid Pioneer complies with voluntary standards," and then lists the standards. The subject devices in the same filing are Vivid Explorer, Vivid Advanced, and Vivid Focus. Pioneer was cleared separately under K251169 on 10 July 2025. Keep the sentence as a wrong name. It is not proof that the hardware is the same. ^{1 5}

How should an HTM team interpret the conflicting 3D statements for Vivid Advanced?
The device description says Advanced includes real-time 3D transducers with multi-plane imaging. The indications comparison says Advanced does not support 3D/4D imaging modes, and the intended-use mode list omits 3D/4D. The summary does not say whether that exclusion is hardware, a license, or a configuration. Do not order a 3D/4D probe or a 3D board from the device-description sentence, and do not treat a later 4D software bullet as restoring the mode. ¹