K153206

Substantially Equivalent

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

Applicant: Fujifilm Medical System U.S.A., Inc.
Product code: FDS
Advisory panel: Gastroenterology, Urology
Date received: 2015-11-05
Decision date: 2016-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.