FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

106 results for "Philips Medical Systems Nederland B.V."
49–72 of 106
Search insights Median review: 89d Cleared: 99% Top manufacturer: Philips Medical Systems Nederland B.V. Lead specialty: Radiology
Cleared Jun 04, 2019
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
K190461 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 98d
Cleared May 29, 2019
Brain Perfusion (BP) application
K182716 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 244d
Cleared Feb 14, 2019
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K183063 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 101d
Cleared Dec 31, 2018
Zenition 50
K183101 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 54d
Cleared Dec 06, 2018
Zenition 70
K183040 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 35d
Cleared Oct 24, 2018
KODEX EPD System
K180940 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 197d
Cleared Aug 03, 2018
Ingenia Ambition S and Ingenia Ambition X
K181479 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Aug 02, 2018
Azurion R2.0
K181830 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 24d
Cleared May 31, 2018
Interventional Workspot
K181177 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Apr 04, 2018
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
K173079 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 187d
Cleared Mar 20, 2018
Ingenia Elition S and Ingenia Elition X
K173451 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 134d
Cleared Mar 06, 2018
Ingenia Elition S and Ingenia Elition X R5.4
K173356 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 132d
Cleared Jan 22, 2018
3D APT
K172920 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Dec 12, 2017
Advanced Diffusion Analysis (ADA) application
K173467 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 34d
Cleared Nov 22, 2017
Azurion series R1.2
K172822 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 65d
Cleared Oct 24, 2017
Dynamic Coronary Roadmap 2.0
K172307 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 85d
Cleared Oct 04, 2017
Philips IntelliSite Pathology Solution
K172174 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 77d
Cleared Jun 02, 2017
Dynamic Coronary Roadmap
K170130 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 140d
Cleared May 11, 2017
Longitudinal Brain Imaging (LoBI) application
K163250 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d
Not Cleared Apr 12, 2017
Philips IntelliSite Pathology Solution
DEN160056 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 132d
Cleared Feb 23, 2017
Lung Nodule Assessment and Comparison Option (LNA)
K162484 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 169d
Cleared Jan 26, 2017
Allura Xper R9
K163715 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 27d
Cleared Jan 06, 2017
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
K163116 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 60d
Cleared Jan 06, 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
K162931 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 79d