510(k) K061976— CKIS-004A INJECTOR SYNCHRONIZATION OPTION

Substantially Equivalent

Toshiba America Medical Systems, In.C

Clearance details

Applicant: Toshiba America Medical Systems, In.C
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2006-07-13
Decision date: 2006-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.