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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 K921008
Device Name VECTOR SERIES
Applicant
Sopha Medical Systems, Inc.
7155 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact RANDY L WEATHERHEAD
Correspondent
Sopha Medical Systems, Inc.
7155 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact RANDY L WEATHERHEAD
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/03/1992
Decision Date 04/27/1992
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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