# K122589: DFP4343C7

- Pathway: 510(k) (Traditional)
- Applicant: Mdi Consultants, Inc.
- Decided: Oct 5, 2012 after 42 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 5 generations back to K981556 (1998). 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)
- K090742: Digital Flat Panel X-Ray Detector, Model LTX240AA01-a, Samsung Mobile Display Co., Ltd. (2009) Summary page 2.

## Indications for use
The Digital X-ray Detector DFP434307 is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

Source page: https://510kreport.com/device/K122589
Methodology: https://510kreport.com/methodology