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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 K210450
Device Name BBX-PET Scanner
Applicant
Prescient Imaging, LLC
12569 Crenshaw Blvd.
Hawthorne,  CA  90250
Applicant Contact Farhad Daghighian
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.1200
Classification Product Code
KPS  
Date Received02/16/2021
Decision Date 03/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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