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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 K211764
Device Name Vereos PET/CT
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684 PC
Applicant Contact Carmit Shmuel
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684 PC
Correspondent Contact Carmit Shmuel
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/08/2021
Decision Date 08/06/2021
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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