OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)— 510(k) K023207

Substantially Equivalent

Toshiba America Medical Systems, In.C

FDA 510(k) clearance K023207 for OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT), Substantially Equivalent on 2002-10-09. Applicant: Toshiba America Medical Systems, In.C.

Clearance details

Applicant: Toshiba America Medical Systems, In.C
Product code: Code LNH
Advisory panel: Radiology
Date received: 2002-09-25
Decision date: 2002-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.