# K210632: Contour ProtegeAI

- Pathway: 510(k) (Traditional)
- Applicant: Mim Software, Inc.
- Decided: Oct 20, 2021 after 231 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: 16 generations back to K954874 (1996). 163 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 169 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193252: Contour ProtegeAI, Mim Software, Inc. (2020) Summary page 4.

## Most influential descendants
- K213976: Contour ProtégéAI (2022), 4 descendants of its own
- K223774: Contour ProtégéAI (2023), 3 descendants of its own
- K231765: Contour ProtégéAI (2023), 2 descendants of its own
- K250035: Contour ProtégéAI+ (2025), 1 descendant of its own
- K253270: Contour ProtégéAI+ (2026), 0 descendants of its own

## 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, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. Segmenting normal structures across a variety of CT anatomical locations. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. 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/K210632
Methodology: https://510kreport.com/methodology