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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 K942837
Device Name DST-XL
Applicant
Sopha Medical Systems, Inc.
7155 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact COLIN J MCNAUGHT
Correspondent
Sopha Medical Systems, Inc.
7155 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact COLIN J MCNAUGHT
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/15/1994
Decision Date 01/05/1995
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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