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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 K894931
Device Name SOPHYCAMERA DSX RECTANGULAR
Applicant
Sopha Medical Systems, Inc.
9110 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact RANDY WEATHERHEAD
Correspondent
Sopha Medical Systems, Inc.
9110 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact RANDY WEATHERHEAD
Regulation Number892.1100
Classification Product Code
IYX  
Date Received08/02/1989
Decision Date 10/27/1989
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
Recalls CDRH Recalls
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