MOBILE C-ARM— 510(k) K121303

Substantially Equivalent

Canon Inc. -Medical Equipment Group

FDA 510(k) clearance K121303 for MOBILE C-ARM, Substantially Equivalent on 2012-07-26. Applicant: Canon Inc. -Medical Equipment Group.

Clearance details

Applicant: Canon Inc. -Medical Equipment Group
Product code: Code OXO
Advisory panel: Radiology
Date received: 2012-05-01
Decision date: 2012-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.