# K112558: Digital Flat Panel X-Ray Detector

- Pathway: 510(k) (Special)
- Applicant: Samsung Mobile Display Co., Ltd.
- Decided: Nov 10, 2011 after 69 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). Our OCR of the scanned summary read K012587, FDA’s number for RF Generators, Disposable Cartridge Kit, Disposable… (Vidamed, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “LLX240AB01”.

## Indications for use
SDX-4343GV digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

Source page: https://510kreport.com/device/K112558
Methodology: https://510kreport.com/methodology