INTEGRA RADIONICS IMAGEFUSION 3

System, Planning, Radiation Therapy Treatment

INTEGRA RADIONICS, INC.

The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Integra Radionics Imagefusion 3.

Pre-market Notification Details

Device IDK063230
510k NumberK063230
Device Name:INTEGRA RADIONICS IMAGEFUSION 3
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
ContactKevin J O'connell
CorrespondentKevin J O'connell
INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-25
Decision Date2006-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M433IF30001 K063230 000

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