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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K913641
Device Name SOPHY NXT
Applicant
Sopha Medical Systems, Inc.
7155 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact RANDY WEATHERHEAD
Correspondent
Sopha Medical Systems, Inc.
7155 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact RANDY WEATHERHEAD
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/13/1991
Decision Date 12/17/1991
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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