# K171194: AS-10, Cxdi-401RF

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: May 24, 2017 after 30 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: 10 generations back to K890348 (1989). 79 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092439: Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF, Virtual Imaging, Inc. (2009) Summary page 4.
- K162909: CSX-30 Flat Panel Detector, Canon, Inc. – Medical Equipment Group (2017) Summary page 4.

## Most influential descendants
- K232298: DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl (2024), 1 descendant of its own
- K252503: Intelligent NR (2026), 0 descendants of its own
- K200887: AS-10 (2020), 0 descendants of its own

## Indications for use
The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Source page: https://510kreport.com/device/K171194
Methodology: https://510kreport.com/methodology