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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 K171303
Device Name Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
Applicant
University of Texas Medical School AT Houston, Texas
6431 Fannin St. Rm. 4.256 Msb
Houston,  TX  77030
Applicant Contact K. Lance Gould
Correspondent
University of Texas Medical School AT Houston, Texas
6431 Fannin St. Rm. 4.256 Msb
Houston,  TX  77030
Correspondent Contact K. Lance Gould
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/03/2017
Decision Date 09/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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