MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER

System, Applicator, Radionuclide, Remote-controlled

VARIAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Mammosource High Dose Rate (hdr) Remote Afterloader.

Pre-market Notification Details

Device IDK040541
510k NumberK040541
Device Name:MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto,  CA  94304
ContactVy Tran
CorrespondentVy Tran
VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto,  CA  94304
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-02
Decision Date2004-03-22
Summary:summary

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