ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY— 510(k) K040719

Substantially Equivalent

Aloka Co., Ltd.

FDA 510(k) clearance K040719 for ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY, Substantially Equivalent on 2004-03-26. Applicant: Aloka Co., Ltd..

Clearance details

Applicant: Aloka Co., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2004-03-19
Decision date: 2004-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, 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.