Contour ProtégéAI+— 510(k) K253270

Name: FDA 510(k) clearance K253270
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

Mim Software, Inc.

FDA 510(k) clearance K253270 for Contour ProtégéAI+, Substantially Equivalent on 2026-03-27. Applicant: Mim Software, Inc.. Device class: 2.

Summary

Mim Software's Contour ProtégéAI+ is filed under QKB, radiological image processing software for radiation therapy. The record doesn't describe the software beyond its name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).

Mim Software filed from Cleveland, Ohio. The decision came 179 calendar days after receipt (September 29, 2025 to March 27, 2026).

Clearance details

Applicant: Mim Software, Inc.
Product code: Product code QKB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-09-29
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QKB

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K262452 — AutoContour (RADAC V6)2026-08-14
K261306 — AI Contouring (VA10A)2026-07-10
K260528 — OncoStudio2026-07-02
K252190 — DeepBT Detector-Plus2026-04-10
K252548 — AI-Rad Companion Organs RT2026-04-10

More clearances from Mim Software, Inc.

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K261763 — MIM KineticID2026-10-26
K251883 — MIM LesionID Pro2025-12-11
K250035 — Contour ProtégéAI+2025-02-03
K243012 — MIM Symphony HDR Fusion2024-10-23
K233620 — MIM - Centiloid Scaling2024-05-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.