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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 K191647
Device Name QLAB Advanced Quantification Software
Applicant
Philips Healthcare
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Applicant Contact Eri Gremi
Correspondent
Philips Healthcare
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Correspondent Contact Eri Gremi
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/20/2019
Decision Date 12/20/2019
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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