MODIFICATION TO: HI-ART SYSTEM

Accelerator, Linear, Medical

TOMOTHERAPY INCORPORATED

The following data is part of a premarket notification filed by Tomotherapy Incorporated with the FDA for Modification To: Hi-art System.

Pre-market Notification Details

Device IDK060912
510k NumberK060912
Device Name:MODIFICATION TO: HI-ART SYSTEM
ClassificationAccelerator, Linear, Medical
Applicant TOMOTHERAPY INCORPORATED 1240 DEMING WAY Madison,  WI  53717
ContactKenneth D Buroker
CorrespondentKenneth D Buroker
TOMOTHERAPY INCORPORATED 1240 DEMING WAY Madison,  WI  53717
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-03
Decision Date2006-04-19
Summary:summary

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