# K141736: Philips Prograde; Philips Eleva Workspot for Digital Diagnost

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Jul 25, 2014 after 28 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K803130 (1981). 28 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140771: Philips Eleva Workspot, Philips Medical Systems Dmc GmbH (2014) Summary page 1.
- K090625: Wireless Portable Detector FD-W17, Philips Medical Systems North America Co. (2009) Summary page 1.

## Most influential descendants
- K182973: DigitalDiagnost C90 (2019), 3 descendants of its own
- K202564: DigitalDiagnost C90 (2020), 2 descendants of its own
- K210692: DigitalDiagnost (2021), 1 descendant of its own
- K171461: SkyPlate Detector for Philips Radiography/Fluoroscopy Systems (2017), 1 descendant of its own
- K212186: Philips Radiology Smart Assistant (2021), 0 descendants of its own

## Recalls of this device
- Sep 19, 2018 · Class II · Z-0239-2019: Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
- Dec 11, 2017 · Class II · Z-0704-2018: It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system. The image remains in the memory of the detec
- May 11, 2017 · Class II · Z-2154-2017: During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
- Nov 10, 2015 · Class II · Z-1695-2016: 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.
- Mar 23, 2015 · Class II · Z-2383-2015: 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 due to a defect in the M
- Feb 9, 2015 · Class II · Z-1554-2015: 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

## Indications for use
As a part of a radiographic system, the Philips Eleva Workspot with SkyPlate Detectors is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyPlate Detectors is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

Source page: https://510kreport.com/device/K141736
Methodology: https://510kreport.com/methodology