# K091435: Digital Radiography Model Cxdi-55G

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: May 29, 2009 after 15 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981556 (1998). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003) Summary page 1.

## Most influential descendants
- K111682: Digital Radiography (2011), 3 descendants of its own
- K153312: Scatter Correction for Cxdi Series (2016), 2 descendants of its own
- K190368: Enhanced Feature Software Pack CXDI Series (2019), 1 descendant of its own
- K212269: Intelligent NR (2021), 0 descendants of its own
- K093790: Simondr DRP (2010), 0 descendants of its own

## Recalls of this device
- Nov 1, 2010 · Class II · Z-2265-2012: Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

## Indications for use
DIGITAL RADIOGRAPHY CXDI-55G provides digital image capture for conventional film/screen radiographic examinations. The device is intended 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/K091435
Methodology: https://510kreport.com/methodology