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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

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