# K023586: DR-ER Verfsion of Canon X-Ray Digital Cameras

- Pathway: 510(k) (Special)
- Applicant: Canon USA, Inc.
- Decided: Nov 5, 2002 after 11 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 K981556 (1998). 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)
- K981556: Canon X-Ray Digital Camera Cxdi-11, Canon USA, Inc. (1998) Summary page 1.
- K992547: Canon X-Ray Digital Camera, Model Cxdi-22, Canon USA, Inc. (1999) Summary page 2.
- K003689: Canon X-Ray Digital Camera, Model Cxdi-31, Canon USA, Inc. (2002) Summary page 3.

## Indications for use
The DR-ER version of Canon’s X-ray Digital Cameras provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screcn systems in all general-purpose diagnostic procedures.

Source page: https://510kreport.com/device/K023586
Methodology: https://510kreport.com/methodology