SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K032329

Substantially Equivalent

Medison America, Inc.

FDA 510(k) clearance K032329 for SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2003-08-06. Applicant: Medison America, Inc..

Clearance details

Applicant: Medison America, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2003-07-29
Decision date: 2003-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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.