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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
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