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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 / March 2026 / K260673

510(k) cleared

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 24, 2026 · K260673

FDA cleared the LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power from GE Medical Systems Ultrasound and Primary Care Diagnostics on Mar 24, 2026 under K260673, 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 Mar 2, 2026. The decision came 22 days later, inside the 90 FDA-day goal for a 510(k).

GE Medical Systems Ultrasound and Primary Care Diagnostics has 8 other decisions in the tracker over the last 12 months: K261933 (Voluson Expert 18; Voluson Expert 20; Voluson Expert 22), K261623 (EchoPAC Software Only / EchoPAC Plug-in (v211)), K261313 (Vivid Explorer/Vivid Advanced/Vivid Focus), K261668 (Venue Go).

Questions & Answers

What did FDA clear under K260673?

K260673 is the FDA 510(k) for LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power, submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics. FDA's decision date was Mar 24, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power?

GE Medical Systems Ultrasound and Primary Care Diagnostics, based in Waukesha, WI, is the applicant of record for K260673.

How long did the K260673 review take?

FDA received the submission on Mar 2, 2026 and issued its decision on Mar 24, 2026, 22 days later.

← All decisions in March 2026

Sources