PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0— 510(k) K122537

Substantially Equivalent

Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical

FDA 510(k) clearance K122537 for PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0, Substantially Equivalent on 2013-04-12. Applicant: Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical.

Clearance details

Applicant: Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
Product code: Code IYN
Advisory panel: Radiology
Date received: 2012-08-20
Decision date: 2013-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, 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.