# K103591: Digital Radiography

- Pathway: 510(k) (Special)
- Applicant: Canon Inc. -Medical Equipment Group
- Decided: Mar 29, 2011 after 112 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: 7 generations back to K981556 (1998). 13 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102012: Digital Radiography, Canon Inc. -Medical Equipment Group (2010) Summary page 1.
- K090623: Digital Radiography Cxdi-40G Compact, Canon USA, Inc. (2009) Summary page 1.
- K062221: Cxdi-40EC, Canon, Inc. (2006) Summary page 1.
- K050987: Digital Radiography Model Cxdi-40EG, Canon, Inc. (2005) Summary page 1.

## Most influential descendants
- K112309: Digital Radiography (2011), 22 descendants of its own
- K131106: Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital Radiography Cxdi-801C Wireless, (2013), 21 descendants of its own
- K170332: Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless (2017), 15 descendants of its own
- K133693: Digital Radiography Cxdi-401C Wireless (2014), 6 descendants of its own
- K212553: DIGITAL RADIOGRAPHY CXDI-Pro, D1 (2021), 3 descendants of its own

## Indications for use
DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.

Source page: https://510kreport.com/device/K103591
Methodology: https://510kreport.com/methodology