MODIFICATION TO HI-ART TREATMENT SYSTEM— 510(k) K082005

Name: FDA 510(k) clearance K082005
Creator: U.S. Food and Drug Administration
Published: 2008-08-25

Substantially Equivalent

Tomotherapy Incorporated

FDA 510(k) clearance K082005 for MODIFICATION TO HI-ART TREATMENT SYSTEM, Substantially Equivalent on 2008-08-25. Applicant: Tomotherapy Incorporated. Device class: 2.

Clearance details

Applicant: Tomotherapy Incorporated
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2008-07-14
Decision date: 2008-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.