# K151014: Aura DR 43C-AG flat panel detector

- Pathway: 510(k) (Traditional)
- Applicant: Abyzr Co., Ltd.
- Decided: Jul 13, 2015 after 88 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: 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)
- K102587: LLX240AB01, Samsung Mobile Display Co., Ltd. (2010) Summary page 5.

## Indications for use
The AURA DR 43C-AG detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

Source page: https://510kreport.com/device/K151014
Methodology: https://510kreport.com/methodology