Philips Medical Systems Nederland B.V. - FDA 510(k) Cleared Devices
106
Total
105
Cleared
1
Denied
106 devices
Cleared
Feb 14, 2019
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Radiology
101d
Cleared
Dec 31, 2018
Zenition 50
Radiology
54d
Cleared
Dec 06, 2018
Zenition 70
Radiology
35d
Cleared
Oct 24, 2018
KODEX EPD System
Cardiovascular
197d
Cleared
Aug 03, 2018
Ingenia Ambition S and Ingenia Ambition X
Radiology
59d
Cleared
Aug 02, 2018
Azurion R2.0
Radiology
24d
Cleared
May 31, 2018
Interventional Workspot
Radiology
29d
Cleared
Apr 04, 2018
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Radiology
187d
Cleared
Mar 20, 2018
Ingenia Elition S and Ingenia Elition X
Radiology
134d
Cleared
Mar 06, 2018
Ingenia Elition S and Ingenia Elition X R5.4
Radiology
132d
Cleared
Jan 22, 2018
3D APT
Radiology
119d
Cleared
Dec 12, 2017
Advanced Diffusion Analysis (ADA) application
Radiology
34d
Cleared
Nov 22, 2017
Azurion series R1.2
Radiology
65d
Cleared
Oct 24, 2017
Dynamic Coronary Roadmap 2.0
Radiology
85d
Cleared
Oct 04, 2017
Philips IntelliSite Pathology Solution
Pathology
77d
Cleared
Jun 02, 2017
Dynamic Coronary Roadmap
Radiology
140d
Cleared
May 11, 2017
Longitudinal Brain Imaging (LoBI) application
Radiology
174d
Not Cleared
Apr 12, 2017
Philips IntelliSite Pathology Solution
Pathology
132d
Cleared
Feb 23, 2017
Lung Nodule Assessment and Comparison Option (LNA)
Radiology
169d
Cleared
Jan 26, 2017
Allura Xper R9
Radiology
27d
Cleared
Jan 06, 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
Radiology
79d
Cleared
Jan 06, 2017
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
Radiology
60d
Cleared
Dec 30, 2016
MultiBand SENSE
Radiology
70d
Cleared
Dec 19, 2016
Multi-Modality Tumor Tracking (MMTT) application
Radiology
56d
Cleared
Dec 02, 2016
Allura Xper FD series and Allura Xper OR Table series
Radiology
51d
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