# K252665: brAIn™ Shoulder Positioning

- Pathway: 510(k) (Traditional)
- Applicant: Avatar Medical
- Decided: Oct 20, 2025 after 56 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 12 generations back to K896095 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213922: FX SPS, Pixee Medical (2022) Summary page 7.

## Indications for use
brAIn™ Shoulder Positioning is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

Source page: https://510kreport.com/device/K252665
Methodology: https://510kreport.com/methodology