# K212186: Philips Radiology Smart Assistant

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Dec 13, 2021 after 153 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K803130 (1981). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210692: DigitalDiagnost, Philips Medical Systems Dmc GmbH (2021) Summary page 4.

## Indications for use
Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image.

Source page: https://510kreport.com/device/K212186
Methodology: https://510kreport.com/methodology