# K232298: DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Apr 26, 2024 after 269 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: 11 generations back to K890348 (1989). 80 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171194: AS-10, Cxdi-401RF, Canon, Inc. (2017) Summary page 4.

## Most influential descendants
- K252503: Intelligent NR (2026), 0 descendants of its own

## Indications for use
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bi is indicated for use in generating radiographic images of human anatomy to replace the radiographic film/screen systems in all general purpose diagnostic procedures. 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. Not intended for mammography applications.

Source page: https://510kreport.com/device/K232298
Methodology: https://510kreport.com/methodology