MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)— 510(k) K990134

Substantially Equivalent

Toshiba America Medical Systems, In.C

FDA 510(k) clearance K990134 for MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI), Substantially Equivalent on 1999-03-19. 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: 1999-01-14
Decision date: 1999-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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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.