# K200887: AS-10

- Pathway: 510(k) (Special)
- Applicant: Canon, Inc.
- Decided: Apr 15, 2020 after 13 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.
No later device cites it as a predicate yet.
0 of 81 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.

## Indications for use
The AS-10 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/K200887
Methodology: https://510kreport.com/methodology