MODIFICATION TO HI-ART TREATMENT SYSTEM

System, Planning, Radiation Therapy Treatment

TOMOTHERAPY INCORPORATED

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

Pre-market Notification Details

Device IDK082005
510k NumberK082005
Device Name:MODIFICATION TO HI-ART TREATMENT SYSTEM
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant TOMOTHERAPY INCORPORATED 1209 DEMING WAY Madison,  WI  53717
ContactRobert Bovy
CorrespondentRobert Bovy
TOMOTHERAPY INCORPORATED 1209 DEMING WAY Madison,  WI  53717
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-14
Decision Date2008-08-25
Summary:summary

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