K073650

Substantially Equivalent

FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371

Applicant
Fujifilm Medical Systems U.S.A, Inc.
Product code
KPR
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deer Field, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR
Other
6
Total
6

Source: openFDA MAUDE database, through . 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.