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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 / April 2026 / K252876

510(k) cleared

GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

Shenzhen RF Tech Co., Ltd. · Apr 1, 2026 · K252876

FDA cleared the GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only from Shenzhen RF Tech Co., Ltd. on Apr 1, 2026 under K252876, a traditional 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 Sep 10, 2025. The decision came 203 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen RF Tech Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252587 (HD 8Ch Wrist Array), K252179 (GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only).

Questions & Answers

What did FDA clear under K252876?

K252876 is the FDA 510(k) for GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only, submitted by Shenzhen RF Tech Co., Ltd.. FDA's decision date was Apr 1, 2026, under product code MOS (Coil, Magnetic Resonance, Specialty).

Who makes the GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only?

Shenzhen RF Tech Co., Ltd., based in Shenzhen, is the applicant of record for K252876.

How long did the K252876 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Apr 1, 2026, 203 days later.

← All decisions in April 2026

Sources