SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS— 510(k) K990970

Substantially Equivalent

Medison America, Inc.

FDA 510(k) clearance K990970 for SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS, Substantially Equivalent on 1999-04-07. Applicant: Medison America, Inc..

Clearance details

Applicant: Medison America, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1999-03-23
Decision date: 1999-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.