ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING— 510(k) K963451

Substantially Equivalent

Topslane

FDA 510(k) clearance K963451 for ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING, Substantially Equivalent on 1997-08-05. Applicant: Topslane.

Clearance details

Applicant: Topslane
Product code: Code IYE
Advisory panel: Radiology
Date received: 1996-09-03
Decision date: 1997-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasnat Hill, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.