# K102012: Digital Radiography

- Pathway: 510(k) (Special)
- Applicant: Canon Inc. -Medical Equipment Group
- Decided: Aug 17, 2010 after 32 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: 6 generations back to K981556 (1998). 9 ancestors in all.
80 later devices descend from it; 6 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091545: Digital Radiography Cxdi-60C, Canon, Inc. (2009) Summary page 1.
- K003689: Canon X-Ray Digital Camera, Model Cxdi-31, Canon USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K103596: Wireless/Wired FDR D-Evo Flat Panel Detector (2011), 54 descendants of its own
- K111548: Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE (2011), 52 descendants of its own
- K132509: FDR D-Evo Flat Panel Detector System (2013), 50 descendants of its own
- K141765: FDR D-Evo Flat Panel Detector System (2014), 32 descendants of its own
- K160997: GC85A (2016), 26 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-70C Wireless provides digital image capture for conventional fil/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/K102012
Methodology: https://510kreport.com/methodology