# K112751: SDX-4343CS

- Pathway: 510(k) (Special)
- Applicant: Samsung Mobile Display Co., Ltd.
- Decided: Nov 23, 2011 after 63 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)
- K102321: Digital Flat Panel X-Ray Detector Model SDX-4336CP, Samsung Mobile Display Co., Ltd. (2011). Our OCR of the scanned summary read K012321, FDA’s number for Point 4 Flowable (Sybron Dental Specialties, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SDX-4336CP”.

## Indications for use
SDX-4343CS Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. 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 who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.

Source page: https://510kreport.com/device/K112751
Methodology: https://510kreport.com/methodology