# K111312: Santeview

- Pathway: 510(k) (Traditional)
- Applicant: Sehyun Co., Ltd.
- Decided: Jul 13, 2011 after 64 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: 6 generations back to K981556 (1998). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024147: Paxscan 4030 Medical Digital Imaging System, Varian Medical Systems, Inc. (2003) Summary page 1.
- K091545: Digital Radiography Cxdi-60C, Canon, Inc. (2009) Summary page 1.
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998) Summary page 1.

## Indications for use
The Sante View-3001C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic filmn/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Source page: https://510kreport.com/device/K111312
Methodology: https://510kreport.com/methodology