Regulatory & ComplianceWhere the FDA Draws the Line: Servicing vs. Remanufacturing for Ultrasound — and What It Means When You Hand a Board or Probe to an ISOAn evidence-based regulatory decision tool mapping FDA's May 2024 final guidance to ultrasound board, probe, and software repair — with a 6-factor activity matrix, regulatory obligations, and a quote-stage buyer evidence checklist.