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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 / December 2025 / K252379

510(k) cleared

AIR Recon DL

Ge Medical Systems, LLC · Dec 23, 2025 · K252379

FDA cleared the AIR Recon DL from Ge Medical Systems, LLC on Dec 23, 2025 under K252379, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 30, 2025. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ge Medical Systems, LLC has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K252379?

K252379 is the FDA 510(k) for AIR Recon DL, submitted by Ge Medical Systems, LLC. FDA's decision date was Dec 23, 2025, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the AIR Recon DL?

Ge Medical Systems, LLC, based in Waukesha, WI, is the applicant of record for K252379.

How long did the K252379 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Dec 23, 2025, 146 days later.

← All decisions in December 2025