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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 / K251883

510(k) cleared

MIM LesionID Pro

Mim Software, Inc. · Dec 11, 2025 · K251883

FDA cleared the MIM LesionID Pro from Mim Software, Inc. on Dec 11, 2025 under K251883, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 20, 2025. The decision came 174 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mim Software, Inc. has one other decision in the tracker over the last 12 months: K253270 (Contour ProtégéAI+).

Questions & Answers

What did FDA clear under K251883?

K251883 is the FDA 510(k) for MIM LesionID Pro, submitted by Mim Software, Inc.. FDA's decision date was Dec 11, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the MIM LesionID Pro?

Mim Software, Inc., based in Cleveland, OH, is the applicant of record for K251883.

How long did the K251883 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Dec 11, 2025, 174 days later.

← All decisions in December 2025

Sources