Aspire Cristalle— 510(k) K212873

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K212873 for Aspire Cristalle, Substantially Equivalent on 2022-05-27. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code MUE
Advisory panel: Radiology
Date received: 2021-09-09
Decision date: 2022-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.