STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE

System, Radiation Therapy, Radionuclide

NUCLETRONIX, INC.

The following data is part of a premarket notification filed by Nucletronix, Inc. with the FDA for Stereotactic 60 Cobalt Gamma System--gammaknife.

Pre-market Notification Details

Device IDK827583
510k NumberK827583
Device Name:STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant NUCLETRONIX, INC. BLACKBURN CENTER Gloucestor,  MA  01930
ContactRoy M Emanuelson
CorrespondentRoy M Emanuelson
NUCLETRONIX, INC. BLACKBURN CENTER Gloucestor,  MA  01930
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-30
Decision Date1982-09-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.