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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 K202679
Device Name Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
Applicant
Mcgovern Medical School
6431 Fannin St., Msb 4.256
Houston,  TX  77030
Applicant Contact K. Lance Gould
Correspondent
Mcgovern Medical School
6431 Fannin St., Msb 4.256
Houston,  TX  77030
Correspondent Contact K. Lance Gould
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/15/2020
Decision Date 04/12/2021
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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