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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 / August 2026 / K253808

510(k) cleared

AIR Recon DL

GE Medical Systems · Aug 13, 2026 · K253808

FDA cleared the AIR Recon DL from GE Medical Systems on Aug 13, 2026 under K253808, 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 Nov 28, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems has 8 other decisions in the tracker over the last 12 months: K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield), K253802 (KHEIRON® Spinal Fixation System, including patient specific K-ROD).

Questions & Answers

What did FDA clear under K253808?

K253808 is the FDA 510(k) for AIR Recon DL, submitted by GE Medical Systems. FDA's decision date was Aug 13, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the AIR Recon DL?

GE Medical Systems, based in Waukesha, WI, is the applicant of record for K253808.

How long did the K253808 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Aug 13, 2026, 258 days later.

← All decisions in August 2026