SOPHYCAMERA DSX RECTANGULAR

Camera, Scintillation (gamma)

SOPHA MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK894931
510k NumberK894931
Device Name:SOPHYCAMERA DSX RECTANGULAR
ClassificationCamera, Scintillation (gamma)
Applicant SOPHA MEDICAL SYSTEMS, INC. 9110 RED BRANCH RD. Columbia,  MD  21045
ContactRandy Weatherhead
CorrespondentRandy Weatherhead
SOPHA MEDICAL SYSTEMS, INC. 9110 RED BRANCH RD. Columbia,  MD  21045
Product CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-02
Decision Date1989-10-27

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