HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS— 510(k) K093466

Name: FDA 510(k) clearance K093466
Creator: U.S. Food and Drug Administration
Published: 2010-06-17

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K093466 for HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS, Substantially Equivalent on 2010-06-17. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.

Clearance details

Applicant: Hitachi Medical Systems America, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2009-11-06
Decision date: 2010-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.