ARIETTA 50— 510(k) K220295

Substantially Equivalent

Fujifilm Healthcare Corporation

FDA 510(k) clearance K220295 for ARIETTA 50, Substantially Equivalent on 2022-04-29. Applicant: Fujifilm Healthcare Corporation.

Clearance details

Applicant: Fujifilm Healthcare Corporation
Product code: Code IYN
Advisory panel: Radiology
Date received: 2022-02-02
Decision date: 2022-04-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kashiwa-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.