# K252503: Intelligent NR

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Apr 30, 2026 after 265 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K890348 (1989). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232298: DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl, Canon, Inc. (2024) Summary page 5.

## 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. It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers. As part of the CXDI Control Software, the Intelligent NR utilizes artificial intelligence based algorithms to reduce noise in fluoroscopic images. Not intended for mammography applications.

Source page: https://510kreport.com/device/K252503
Methodology: https://510kreport.com/methodology