AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM— 510(k) K072606

Substantially Equivalent

Toshiba America Medical Systems, In.C

FDA 510(k) clearance K072606 for AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM, Substantially Equivalent on 2007-10-02. Applicant: Toshiba America Medical Systems, In.C.

Clearance details

Applicant: Toshiba America Medical Systems, In.C
Product code: Code JAK
Advisory panel: Radiology
Date received: 2007-09-17
Decision date: 2007-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.