# K253270: Contour ProtégéAI+

- Pathway: 510(k) (Traditional)
- Applicant: Mim Software, Inc.
- Decided: Mar 27, 2026 after 179 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K954874 (1996). 168 ancestors in all.
No later device cites it as a predicate yet.
1 of 169 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250035: Contour ProtégéAI+, Mim Software, Inc. (2025) Summary page 5.

## Indications for use
Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications: Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, aiding image registration, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. Segmenting structures across a variety of CT and MR anatomical locations. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.

Source page: https://510kreport.com/device/K253270
Methodology: https://510kreport.com/methodology