# K163410: DigitalDiagnost C50

- Pathway: 510(k) (Special)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Jan 4, 2017 after 30 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001201 (2000). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141381: Duradiagnost, Philips Healthcare (Suzhou) Co., Ltd. (2014) Summary page 6.

## Most influential descendants
- K201725: DigitalDiagnost C50 (2020), 0 descendants of its own

## Recalls of this device
- Mar 9, 2023 · Class II · Z-1383-2023: If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidabl
- Mar 9, 2023 · Class II · Z-1382-2023: If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidabl
- Feb 25, 2022 · Class II · Z-1563-2022: 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 the image on the first examination d
- Dec 21, 2018 · Class II · Z-2498-2019: During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and 

## Indications for use
The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K163410
Methodology: https://510kreport.com/methodology