AS-10— 510(k) K200887

Name: FDA 510(k) clearance K200887
Creator: U.S. Food and Drug Administration
Published: 2020-04-15

Substantially Equivalent

Canon, Inc.

FDA 510(k) clearance K200887 for AS-10, Substantially Equivalent on 2020-04-15. Applicant: Canon, Inc.. Device class: 2.

Clearance details

Applicant: Canon, Inc.
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2020-04-02
Decision date: 2020-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Kawasaki, JP

Download summary PDF View on FDA.gov ↗

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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.