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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 K181343
Device Name HeartSee Cardiac P.E.T. Processing Software
Applicant
Bracco Diagnostics, Inc.
259 Prospect Plains Rd., Bldg. H
Monroe Township,  NE  08831
Applicant Contact Patrice Marchildon
Correspondent
Bracco Diagnostics, Inc.
259 Prospect Plains Rd., Bldg. H
Monroe Township,  NJ  08831
Correspondent Contact Patrice Marchildon
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/21/2018
Decision Date 06/12/2018
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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