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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K200974
Device Name QLAB Advanced Quantification Software
Applicant
Philips Health Care
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Applicant Contact Travis Catania
Correspondent
Philips Health Care
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Correspondent Contact Travis Catania
Regulation Number892.2050
Classification Product Code
QIH  
Date Received04/13/2020
Decision Date 06/03/2020
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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