# K213780: DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Jan 24, 2022 after 53 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: 11 generations back to K981556 (1998). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170332: Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless, Canon, Inc. (2017) Summary page 4.

## Most influential descendants
- K221620: Digital Radiography CXDI-Elite, Digital Radiography E1 (2022), 1 descendant of its own
- K222687: Digital Radiography CXDI-Elite, Digital Radiography E1 (2022), 0 descendants of its own

## 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/K213780
Methodology: https://510kreport.com/methodology