# K242925: MR Contour DL

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 1, 2025 after 189 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). 102 ancestors in all.
No later device cites it as a predicate yet.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230082: Auto Segmentation, Ge Medical Systems, LLC (2023) Summary page 5.

## Indications for use
MR Contour DL generates a Radiotherapy Structure Set (RTSS) DICOM with segmented organs at risk which can be used by trained medical professionals. It is intended to aid in radiation therapy planning by generating initial contours to accelerate workflow for radiation therapy planning. It is the responsibility of the user to verify the processed output contours and user-defined labels for each organ at risk and correct the contours/labels as needed. MR Contour DL is intended to be used with images acquired on MR scanners, in adult patients.

Source page: https://510kreport.com/device/K242925
Methodology: https://510kreport.com/methodology