# K203610: Automatic Anatomy Recognition (AAR)

- Pathway: 510(k) (Traditional)
- Applicant: Quantitative Radiology Solutions, LLC
- Decided: Apr 20, 2021 after 131 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
Automatic Anatomy Recognition (AAR) is a software-only medical device intended for use by technicians and trained physicians to derive contours of anatomical structures from computed tomography studies for input to a radiation treatment planning system. It is only intended to work for anatomical structures in the head & neck and thoracic body regions. It is not for use on patients below 18 years of age and it relies on third party treatment planning systems to display and edit the contours.

Source page: https://510kreport.com/device/K203610
Methodology: https://510kreport.com/methodology