DS-7 NUCLEAR MEDICINE GAMMA CAMERA

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 Ds-7 Nuclear Medicine Gamma Camera.

Pre-market Notification Details

Device IDK872297
510k NumberK872297
Device Name:DS-7 NUCLEAR MEDICINE GAMMA CAMERA
ClassificationCamera, Scintillation (gamma)
Applicant SOPHA MEDICAL SYSTEMS, INC. 9110 RED BRANCH RD. Columbia,  MD  21045
ContactPhyllis C Dillinger
CorrespondentPhyllis C Dillinger
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 Received1987-06-16
Decision Date1987-08-12

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