# K231855: QOCA® image Smart RT Contouring System

- Pathway: 510(k) (Traditional)
- Applicant: Quanta Computer, Inc.
- Decided: Feb 13, 2024 after 235 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: 15 generations back to K954874 (1996). 101 ancestors in all.
No later device cites it as a predicate yet.
1 of 102 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191928: AccuContour, Xiamen Manteia Technology, Ltd. (2020) Summary page 4.

## Indications for use
QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms. Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System. The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used by radiation oncology department. QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface. The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

Source page: https://510kreport.com/device/K231855
Methodology: https://510kreport.com/methodology