# K052136: GR17 Digital Detector

- Pathway: 510(k) (Special)
- Applicant: Anrad Corp.
- Decided: Aug 25, 2005 after 20 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: 2 generations back to K951373 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042821: Digital Detector, Model GR17, Anrad Corp. (2004) Summary page 1.
- K973206: Sterling Diagnostic Imaging Direct Radiography, Sterling Diagnostic Imaging, Inc. (1997) Summary page 1.

## Indications for use
The GR17 is a selenium-based direct conversion DR detector intended for use by a qualified/trained doctor or technician and is designed to perform radlographlc images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. The GR17 is not used for mammography.

Source page: https://510kreport.com/device/K052136
Methodology: https://510kreport.com/methodology