HITACHI VERSIFLEX— 510(k) K991231

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K991231 for HITACHI VERSIFLEX, Substantially Equivalent on 1999-05-24. Applicant: Hitachi Medical Systems America, Inc..

Clearance details

Applicant: Hitachi Medical Systems America, Inc.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1999-04-12
Decision date: 1999-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.