# K222687: Digital Radiography CXDI-Elite, Digital Radiography E1

- Pathway: 510(k) (Special)
- Applicant: Canon, Inc.
- Decided: Sep 29, 2022 after 23 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: 13 generations back to K981556 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221620: Digital Radiography CXDI-Elite, Digital Radiography E1, Canon, Inc. (2022) Summary page 4.

## Indications for use
The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Source page: https://510kreport.com/device/K222687
Methodology: https://510kreport.com/methodology