510(k) K111646— ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

Substantially Equivalent

Fujifilm Medical System U.S.A., Inc.

Clearance details

Applicant: Fujifilm Medical System U.S.A., Inc.
Product code: Code MUE
Advisory panel: Radiology
Date received: 2011-06-13
Decision date: 2011-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.