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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 / K260947

510(k) cleared

0.55T 12Ch Breast Coil

Neocoil, LLC · Apr 23, 2026 · K260947

FDA cleared the 0.55T 12Ch Breast Coil from Neocoil, LLC on Apr 23, 2026 under K260947, a special 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 Mar 23, 2026. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Neocoil, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260947?

K260947 is the FDA 510(k) for 0.55T 12Ch Breast Coil, submitted by Neocoil, LLC. FDA's decision date was Apr 23, 2026, under product code MOS (Coil, Magnetic Resonance, Specialty).

Who makes the 0.55T 12Ch Breast Coil?

Neocoil, LLC, based in Pewaukee, WI, is the applicant of record for K260947.

How long did the K260947 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Apr 23, 2026, 31 days later.

← All decisions in April 2026