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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 K952190
Device Name TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE
Applicant
SOPHA MEDICAL SYSTEMS, INC.
14900 SWEITZER LN.
SUITE 200
LAUREL,  MD  20707
Applicant Contact LONNIE MIXON
Correspondent
SOPHA MEDICAL SYSTEMS, INC.
14900 SWEITZER LN.
SUITE 200
LAUREL,  MD  20707
Correspondent Contact LONNIE MIXON
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/09/1995
Decision Date 01/18/1996
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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