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Philips Health Care

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K201352 3D Auto LAALLZ2020-08-17 View
510(k) K200974 QLAB Advanced Quantification SoftwareQIH2020-06-03 View
510(k) K200179 Collaboration LiveLLZ2020-02-18 View
510(k) K191647 QLAB Advanced Quantification SoftwareQIH2019-12-20 View
510(k) K192226 Lumify Diagnostic Ultrasound SystemIYN2019-09-06 View
510(k) K190913 QLAB Advanced Quantification Software 13LLZ2019-06-18 View
510(k) K172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2017-10-04 View
510(k) K171314 QLAB Advanced Quantification SoftwareLLZ2017-05-30 View
510(k) K163020 Xperius Ultrasound SystemIYN2016-11-16 View
510(k) K162549 Lumify Ultrasound SystemIYN2016-10-03 View
510(k) K162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemIYN2016-09-14 View
510(k) K132087 PERCUNAV SYSTEMJAK2013-07-24 View
510(k) K130159 QLAB QUANTIFICATION SOFTWARE HEART MODELLLZ2013-05-13 View
510(k) K121498 PERCUNAVJAK2012-12-14 View
510(k) K121638 ST80I STRESS TEST SYSTEMDQK2012-07-18 View
510(k) K120855 INTELLISPACE ECGDQK2012-06-29 View
510(k) K120321 CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-02-17 View
510(k) K112959 CALG-STR EXERCISE ECG ANALYSIS ALGORITHMDPS2012-01-26 View
510(k) K110151 ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TLNH2011-03-22 View
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