ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER— 510(k) K974544

Substantially Equivalent

Aloka Co., Ltd.

FDA 510(k) clearance K974544 for ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER, Substantially Equivalent on 1998-03-18. Applicant: Aloka Co., Ltd..

Clearance details

Applicant: Aloka Co., Ltd.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1997-12-04
Decision date: 1998-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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.