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FDA 510(k) Applications Submitted by Philips Healthcare
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190913
04/08/2019
QLAB Advanced Quantification Software 13
Philips Healthcare
K162549
09/13/2016
Lumify Ultrasound System
Philips Healthcare
K132087
07/05/2013
PERCUNAV SYSTEM
PHILIPS HEALTHCARE
K191647
06/20/2019
QLAB Advanced Quantification Software
Philips Healthcare
K121638
06/04/2012
ST80I STRESS TEST SYSTEM
PHILIPS HEALTHCARE
K120855
03/21/2012
INTELLISPACE ECG
PHILIPS HEALTHCARE
K112959
10/04/2011
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
PHILIPS HEALTHCARE
K110151
01/18/2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
PHILIPS HEALTHCARE
K162329
08/19/2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
Philips Healthcare
K172607
08/30/2017
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 System
Philips Healthcare
K200179
01/24/2020
Collaboration Live
Philips Healthcare
K192226
08/16/2019
Lumify Diagnostic Ultrasound System
Philips Healthcare
K130159
01/23/2013
QLAB QUANTIFICATION SOFTWARE HEART MODEL
PHILIPS HEALTHCARE
K171314
05/04/2017
QLAB Advanced Quantification Software
Philips Healthcare
K120321
02/02/2012
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS HEALTHCARE
K153480
12/02/2015
ClearVue850 Diagnostic Ultrasound System
PHILIPS HEALTHCARE
K163020
10/31/2016
Xperius Ultrasound System
PHILIPS HEALTHCARE
K121498
05/21/2012
PERCUNAV
PHILIPS HEALTHCARE
K200974
04/13/2020
QLAB Advanced Quantification Software
Philips Healthcare
K201352
05/21/2020
3D Auto LAA
Philips Healthcare
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