SONOACE 6000/ ULTRAMARK 400— 510(k) K981510

Substantially Equivalent

Medison America, Inc.

FDA 510(k) clearance K981510 for SONOACE 6000/ ULTRAMARK 400, Substantially Equivalent on 1998-05-08. Applicant: Medison America, Inc..

Clearance details

Applicant: Medison America, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1998-04-28
Decision date: 1998-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, 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.