SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K943637

Substantially Equivalent

Aloka Co., Ltd.

FDA 510(k) clearance K943637 for SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 1994-12-29. Applicant: Aloka Co., Ltd..

Clearance details

Applicant: Aloka Co., Ltd.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1994-07-27
Decision date: 1994-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.