CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION— 510(k) K063241

Substantially Equivalent

Toshiba America Medical Systems, In.C

FDA 510(k) clearance K063241 for CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION, Substantially Equivalent on 2006-11-09. 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: 2006-10-26
Decision date: 2006-11-09
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.