K173132

Substantially Equivalent

ASPIRE Cristalle

Applicant: Fujifilm Medical Systems U.S.A, Inc.
Product code: MUE
Advisory panel: Radiology
Date received: 2017-09-29
Decision date: 2017-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Stamford, CT, US

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.