VECTOR SERIES

System, Tomography, Computed, Emission

SOPHA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Vector Series.

Pre-market Notification Details

Device IDK921008
510k NumberK921008
Device Name:VECTOR SERIES
ClassificationSystem, Tomography, Computed, Emission
Applicant SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia,  MD  21046 -2101
ContactRandy L Weatherhead
CorrespondentRandy L Weatherhead
SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia,  MD  21046 -2101
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-03
Decision Date1992-04-27

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