MIM LesionID Pro
FDA 510(k) K251883 · Mim Software, Inc.
510(k) numberK251883
Submission
- Device name
- MIM LesionID Pro
- Applicant
- Mim Software, Inc.
Cleveland, OH, US - Received
- June 20, 2025
- Decision date
- December 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MIM LesionID Pro cleared by the FDA?
MIM LesionID Pro (K251883) received a 510(k) decision of Substantially Equivalent on December 11, 2025, 174 days after the submission was received.
What is the product code of K251883?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.