# K131483: Philips Pixium 4343RC

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Oct 7, 2013 after 137 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: 3 generations back to K931071 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998) Summary page 1.
- K090625: Wireless Portable Detector FD-W17, Philips Medical Systems North America Co. (2009) Summary page 1.

## Most influential descendants
- K170113: pixium 4343RCE (2017), 0 descendants of its own

## Indications for use
As a part of a radiographic system, the Pixium 4343RC is intended to acquire digital radiographic images. The Pixium 4343RC 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/K131483
Methodology: https://510kreport.com/methodology