# K070829: Synepix 4600 Detector

- Pathway: 510(k) (Abbreviated)
- Applicant: Analogic Corporation
- Decided: May 9, 2007 after 44 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: 1 generation back to K051483 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051483: Kodak Directview DR System Detector, Eastman Kodak Company (2005) Summary page 1.

## Indications for use
The SynePix 4600 is Thallium-doped Cesium Iodide and amorphous Silicon (a-Si) Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. The detector will be used with Analogic AN6255 and AN6265 (SyneRad Omni and SyneRad Omni RT) Systems. The AN6255 has a single tall stand and single detector, the AN6265 is a dual detector system with a tall stand and short stand. The detector is not for use for mammography.

Source page: https://510kreport.com/device/K070829
Methodology: https://510kreport.com/methodology