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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K872297
Device Name DS-7 NUCLEAR MEDICINE GAMMA CAMERA
Applicant
Sopha Medical Systems, Inc.
9110 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact PHYLLIS C DILLINGER
Correspondent
Sopha Medical Systems, Inc.
9110 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact PHYLLIS C DILLINGER
Regulation Number892.1100
Classification Product Code
IYX  
Date Received06/16/1987
Decision Date 08/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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