AU5 ULTRASOUND IMAGING SYSTEM— 510(k) K980468

Substantially Equivalent

Biosound Esaote, Inc.

FDA 510(k) clearance K980468 for AU5 ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 1998-08-26. Applicant: Biosound Esaote, Inc..

Clearance details

Applicant: Biosound Esaote, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1998-02-06
Decision date: 1998-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.