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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 -2101
Applicant Contact RANDY WEATHERHEAD
Correspondent
SOPHA MEDICAL SYSTEMS, INC.
7155 COLUMBIA GATEWAY DR.
COLUMBIA,  MD  21046 -2101
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
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