AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)— 510(k) K014168

Substantially Equivalent

Biosound Esaote, Inc.

FDA 510(k) clearance K014168 for AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION), Substantially Equivalent on 2002-04-25. Applicant: Biosound Esaote, Inc..

Clearance details

Applicant: Biosound Esaote, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2001-12-19
Decision date: 2002-04-25
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.