APEX 115 NUCLEAR MEDICINE PROCESSOR

Camera, Scintillation (gamma)

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Apex 115 Nuclear Medicine Processor.

Pre-market Notification Details

Device IDK884672
510k NumberK884672
Device Name:APEX 115 NUCLEAR MEDICINE PROCESSOR
ClassificationCamera, Scintillation (gamma)
Applicant ELSCINT, INC. 930 COMMONWEALTH AVE. Boston,  MA  02215
ContactSobel
CorrespondentSobel
ELSCINT, INC. 930 COMMONWEALTH AVE. Boston,  MA  02215
Product CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-08
Decision Date1989-04-17

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