# K170113: pixium 4343RCE

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Feb 9, 2017 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931071 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131483: Philips Pixium 4343RC, Philips Medical Systems Dmc GmbH (2013) Summary page 4.

## Indications for use
As a part of a radiographic system, the Pixium 4343RCE is intended to acquire digital radiographic images. The Pixium 4343RCE 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/K170113
Methodology: https://510kreport.com/methodology