HR12000 ULTRASOUND SYSTEM— 510(k) K961229

Substantially Equivalent

International Ultrasound Corp.

FDA 510(k) clearance K961229 for HR12000 ULTRASOUND SYSTEM, Substantially Equivalent on 1997-05-29. Applicant: International Ultrasound Corp..

Clearance details

Applicant: International Ultrasound Corp.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1996-03-29
Decision date: 1997-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, NJ, US

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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.