MAMMOSITE II RADIATION THERAPY SYSTEM

System, Applicator, Radionuclide, Remote-controlled

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Mammosite Ii Radiation Therapy System.

Pre-market Notification Details

Device IDK091378
510k NumberK091378
Device Name:MAMMOSITE II RADIATION THERAPY SYSTEM
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
ContactJennifer Sullivan
CorrespondentJennifer Sullivan
HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-11
Decision Date2009-07-02
Summary:summary

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