# K141381: Duradiagnost

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Jun 12, 2014 after 16 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001201 (2000). 21 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103448: Brivo XR385, Ge Medical Systems, LLC (2011) Summary page 1.
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998) Summary page 2.
- K123005: Ddrversa Motion, Swissray Medical AG (2012) Summary page 2.

## Most influential descendants
- K163410: DigitalDiagnost C50 (2017), 1 descendant of its own
- K201725: DigitalDiagnost C50 (2020), 0 descendants of its own
- K201640: DuraDiagnost (2020), 0 descendants of its own

## 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.
- May 31, 2017 · Class II · Z-2322-2017: Tube arm assembly could fall down due to cracked welding joints
- Nov 10, 2015 · Class II · Z-1696-2016: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
- Sep 17, 2015 · Class II · Z-2682-2016: Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the 
- Feb 9, 2015 · Class II · Z-1555-2015: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to co
- Jan 23, 2015 · Class II · Z-1251-2015: Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.

## 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/K141381
Methodology: https://510kreport.com/methodology