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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K203216
Device Name The Multimodality Advanced Vessel Analysis
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
PC Best,  NL 5684
Applicant Contact Vered Nitzan
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Codes
LLZ   LNH  
Date Received11/02/2020
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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