# K232928: DeepContour (V1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Wisdom Technologies., Inc.
- Decided: May 7, 2024 after 230 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: 17 generations back to K954874 (1996). 103 ancestors in all.
No later device cites it as a predicate yet.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221305: AI-Rad Companion Organs RT, Siemens Medical Solutions USA, Inc. (2022) Summary page 4.

## Indications for use
DeepContour is a deep learning based medical imaging software that allows trained healthcare professionals to use DeepContour as a tool to automatically process CT images. In addition, DeepCoutour is suitable for the following conditions: 1. Creation of contours using deep-learning algorithms , support quantitative analysis, organ HU distribution statistics, transfer contour files to TPS, and create management archives for patients. 2. Analyze the anatomical structure at different anatomical positions. 3. Rigid and elastic registration based on CT. 4. 3D reconstruction, editing and other visual tools based on organ contours

Source page: https://510kreport.com/device/K232928
Methodology: https://510kreport.com/methodology