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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K190913
Device Name QLAB Advanced Quantification Software 13
Applicant
Philips Health Care
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Applicant Contact Arti Arvind
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/08/2019
Decision Date 06/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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