# K201640: DuraDiagnost

- Pathway: 510(k) (Special)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Jul 9, 2020 after 23 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (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.
No later device cites it as a predicate yet.
0 of 23 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 4.

## Recalls of this device
- Mar 10, 2025 · Class II · Z-1553-2025: Potential for collimator to fall as a result of incorrect installation.
- Mar 10, 2025 · Class II · Z-1554-2025: Potential for collimator to fall as a result of incorrect installation.

## Indications for use
The DuraDiagnost 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/K201640
Methodology: https://510kreport.com/methodology