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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 / January 2026 / K253738

510(k) cleared

3.0T AIR 32CH HNA

Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 23, 2026 · K253738

FDA cleared the 3.0T AIR 32CH HNA from Ge Healthcare Coils (Usa Instruments, Inc.) on Jan 23, 2026 under K253738, a abbreviated 510(k). The device falls under product code MOS, Coil, Magnetic Resonance, Specialty, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 24, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ge Healthcare Coils (Usa Instruments, Inc.) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253738?

K253738 is the FDA 510(k) for 3.0T AIR 32CH HNA, submitted by Ge Healthcare Coils (Usa Instruments, Inc.). FDA's decision date was Jan 23, 2026, under product code MOS (Coil, Magnetic Resonance, Specialty).

Who makes the 3.0T AIR 32CH HNA?

Ge Healthcare Coils (Usa Instruments, Inc.), based in Aurora, OH, is the applicant of record for K253738.

How long did the K253738 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jan 23, 2026, 60 days later.

← All decisions in January 2026