# K212269: Intelligent NR

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Sep 17, 2021 after 59 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). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190368: Enhanced Feature Software Pack CXDI Series, Canon, Inc. (2019) Summary page 4.

## Indications for use
As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

Source page: https://510kreport.com/device/K212269
Methodology: https://510kreport.com/methodology