Medical Device Manufacturer · US , Bothell , WA

Philips Health Care - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2011
20
Total
20
Cleared
0
Denied

FDA 510(k) cleared devices by Philips Health Care Radiology

17 devices
1-17 of 17
Cleared Aug 17, 2020
3D Auto LAA
K201352 · LLZ
Radiology · 88d
Cleared Jun 03, 2020
QLAB Advanced Quantification Software
K200974 · QIH
Radiology · 51d
Cleared Feb 18, 2020
Collaboration Live
K200179 · LLZ
Radiology · 25d
Cleared Dec 20, 2019
QLAB Advanced Quantification Software
K191647 · QIH
Radiology · 183d
Cleared Sep 06, 2019
Lumify Diagnostic Ultrasound System
K192226 · IYN
Radiology · 21d
Cleared Jun 18, 2019
QLAB Advanced Quantification Software 13
K190913 · LLZ
Radiology · 71d
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Radiology · 35d
Cleared May 30, 2017
QLAB Advanced Quantification Software
K171314 · LLZ
Radiology · 26d
Cleared Nov 16, 2016
Xperius Ultrasound System
K163020 · IYN
Radiology · 16d
Cleared Oct 03, 2016
Lumify Ultrasound System
K162549 · IYN
Radiology · 20d
Cleared Sep 14, 2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K162329 · IYN
Radiology · 26d
Cleared Dec 16, 2015
ClearVue850 Diagnostic Ultrasound System
K153480 · IYN
Radiology · 14d
Cleared Jul 24, 2013
PERCUNAV SYSTEM
K132087 · JAK
Radiology · 19d
Cleared May 13, 2013
QLAB QUANTIFICATION SOFTWARE HEART MODEL
K130159 · LLZ
Radiology · 110d
Cleared Dec 14, 2012
PERCUNAV
K121498 · JAK
Radiology · 207d
Cleared Feb 17, 2012
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
K120321 · IYN
Radiology · 15d
Cleared Mar 22, 2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
K110151 · LNH
Radiology · 63d
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