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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 / January 2026 / K253366

510(k) cleared

LOGIQ Fortis

GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 7, 2026 · K253366

FDA cleared the LOGIQ Fortis from GE Medical Systems Ultrasound and Primary Care Diagnostics on Jan 7, 2026 under K253366, 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 Sep 30, 2025. The decision came 99 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 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 K253366?

K253366 is the FDA 510(k) for LOGIQ Fortis, submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics. FDA's decision date was Jan 7, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the LOGIQ Fortis?

GE Medical Systems Ultrasound and Primary Care Diagnostics, based in Waukesha, WI, is the applicant of record for K253366.

How long did the K253366 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jan 7, 2026, 99 days later.

← All decisions in January 2026