SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K012080

Substantially Equivalent

Aloka Co., Ltd.

FDA 510(k) clearance K012080 for SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2001-08-29. Applicant: Aloka Co., Ltd..

Clearance details

Applicant: Aloka Co., Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2001-07-03
Decision date: 2001-08-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wallingford, CT, 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.