SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING— 510(k) K991842

Substantially Equivalent

Ge Vingmed Ultrasound

FDA 510(k) clearance K991842 for SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING, Substantially Equivalent on 1999-06-11. Applicant: Ge Vingmed Ultrasound.

Clearance details

Applicant: Ge Vingmed Ultrasound
Product code: Code IYO
Advisory panel: Radiology
Date received: 1999-05-28
Decision date: 1999-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horten, NO

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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.