# K210692: DigitalDiagnost

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Apr 2, 2021 after 25 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K803130 (1981). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202564: DigitalDiagnost C90, Philips Medical Systems Dmc GmbH (2020) Summary page 4.

## Most influential descendants
- K212186: Philips Radiology Smart Assistant (2021), 0 descendants of its own

## Recalls of this device
- Oct 1, 2025 · Class II · Z-0464-2026: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion requ
- Sep 21, 2023 · Class II · Z-0277-2024: Potential for units suspended on the ceiling to fail and fall.
- Sep 21, 2023 · Class II · Z-0272-2024: Potential for units suspended on the ceiling to fail and fall.
- Sep 21, 2023 · Class II · Z-0278-2024: Potential for units suspended on the ceiling to fail and fall.
- Sep 21, 2023 · Class II · Z-0273-2024: Potential for units suspended on the ceiling to fail and fall.
- Sep 21, 2023 · Class II · Z-0274-2024: Potential for units suspended on the ceiling to fail and fall.
- May 19, 2021 · Class II · Z-1327-2022: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due t
- May 19, 2021 · Class II · Z-1326-2022: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due t

## Indications for use
The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography

Source page: https://510kreport.com/device/K210692
Methodology: https://510kreport.com/methodology