MODIFICATION TO: HI-ART SYSTEM— 510(k) K060912

Substantially Equivalent

Tomotherapy Incorporated

FDA 510(k) clearance K060912 for MODIFICATION TO: HI-ART SYSTEM, Substantially Equivalent on 2006-04-19. Applicant: Tomotherapy Incorporated.

Clearance details

Applicant: Tomotherapy Incorporated
Product code: Code IYE
Advisory panel: Radiology
Date received: 2006-04-03
Decision date: 2006-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, 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.