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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 / December 2025 / K252922

510(k) cleared

Neosoma Brain Mets

Neosoma, Inc. · Dec 17, 2025 · K252922

FDA cleared the Neosoma Brain Mets from Neosoma, Inc. on Dec 17, 2025 under K252922, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 15, 2025. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K252922?

K252922 is the FDA 510(k) for Neosoma Brain Mets, submitted by Neosoma, Inc.. FDA's decision date was Dec 17, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Neosoma Brain Mets?

Neosoma, Inc., based in Groton, MA, is the applicant of record for K252922.

How long did the K252922 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Dec 17, 2025, 93 days later.

← All decisions in December 2025