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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K261933

510(k) cleared

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · Oct 2, 2026 · K261933

FDA cleared the Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 from GE Medical Systems Ultrasound and Primary care Diagnostics, LLC on Oct 2, 2026 under K261933, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 9, 2026. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC has 8 other decisions in the tracker over the last 12 months: K261623 (EchoPAC Software Only / EchoPAC Plug-in (v211)), K261313 (Vivid Explorer/Vivid Advanced/Vivid Focus), K261668 (Venue Go), K261835 (LOGIQ Focus).

Questions & Answers

What did FDA clear under K261933?

K261933 is the FDA 510(k) for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22, submitted by GE Medical Systems Ultrasound and Primary care Diagnostics, LLC. FDA's decision date was Oct 2, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC, based in Waukesha, WI, is the applicant of record for K261933.

How long did the K261933 review take?

FDA received the submission on Jun 9, 2026 and issued its decision on Oct 2, 2026, 115 days later.

← All decisions in October 2026