# K153318: Philips Eleva Workspot with SkyFlow

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Dec 22, 2015 after 34 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K803130 (1981). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 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 4.

## Indications for use
As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow 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/K153318
Methodology: https://510kreport.com/methodology