HI-ART SYSTEM— 510(k) K042739

Substantially Equivalent

Tomotherapy Incorporated

FDA 510(k) clearance K042739 for HI-ART SYSTEM, Substantially Equivalent on 2004-11-03. 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: 2004-10-04
Decision date: 2004-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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K033347 — MODIFICATION TO: HI-ART SYSTEM2003-11-12

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