DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl— 510(k) K232298

Substantially Equivalent

Canon, Inc.

FDA 510(k) clearance K232298 for DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl, Substantially Equivalent on 2024-04-26. Applicant: Canon, Inc..

Clearance details

Applicant: Canon, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2023-08-01
Decision date: 2024-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kawasaki, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.