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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 / February 2026 / K253779

510(k) cleared

SIGNA Sprint Select

Ge Medical Systems, LLC · Feb 5, 2026 · K253779

FDA cleared the SIGNA Sprint Select from Ge Medical Systems, LLC on Feb 5, 2026 under K253779, 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 26, 2025. The decision came 71 days later, inside the 90 FDA-day goal for a 510(k).

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 K253779?

K253779 is the FDA 510(k) for SIGNA Sprint Select, submitted by Ge Medical Systems, LLC. FDA's decision date was Feb 5, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the SIGNA Sprint Select?

Ge Medical Systems, LLC, based in Waukesha, WI, is the applicant of record for K253779.

How long did the K253779 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Feb 5, 2026, 71 days later.

← All decisions in February 2026