# K202564: DigitalDiagnost C90

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Sep 30, 2020 after 26 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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: 10 generations back to K803130 (1981). 30 ancestors in all.
2 later devices descend 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)
- K182973: DigitalDiagnost C90, Philips Medical Systems Dmc GmbH (2019) Summary page 4.

## Most influential descendants
- K210692: DigitalDiagnost (2021), 1 descendant of its own
- K212186: Philips Radiology Smart Assistant (2021), 0 descendants of its own

## Recalls of this device
- May 1, 2026 · Class II · Z-2354-2026: System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
- Oct 1, 2025 · Class II · Z-0465-2026: 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-0275-2024: Potential for units suspended on the ceiling to fail and fall.
- Sep 21, 2023 · Class II · Z-0276-2024: Potential for units suspended on the ceiling to fail and fall.
- May 19, 2023 · Class II · Z-2042-2023: There is a software login in issue that may prevent the user from logging in.
- Sep 22, 2021 · Class II · Z-0239-2022: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 
- May 19, 2021 · Class II · Z-1328-2022: 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-1329-2022: 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 C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 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/K202564
Methodology: https://510kreport.com/methodology