SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM— 510(k) K910342

Substantially Equivalent

Medison Co., Ltd.

FDA 510(k) clearance K910342 for SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 1991-08-19. Applicant: Medison Co., Ltd..

Clearance details

Applicant: Medison Co., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1991-01-28
Decision date: 1991-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kang Won-Do, KR

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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.