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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 / March 2026 / K253270

510(k) cleared

Contour ProtégéAI+

Mim Software, Inc. · Mar 27, 2026 · K253270

FDA cleared the Contour ProtégéAI+ from Mim Software, Inc. on Mar 27, 2026 under K253270, a traditional 510(k). The device falls under product code QKB, Radiological Image Processing Software For Radiation Therapy, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 179 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: K251883 (MIM LesionID Pro).

Questions & Answers

What did FDA clear under K253270?

K253270 is the FDA 510(k) for Contour ProtégéAI+, submitted by Mim Software, Inc.. FDA's decision date was Mar 27, 2026, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the Contour ProtégéAI+?

Mim Software, Inc., based in Cleveland, OH, is the applicant of record for K253270.

How long did the K253270 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Mar 27, 2026, 179 days later.

← All decisions in March 2026

Sources