Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

107 results for "Philips Medical Systems Nederland B.V."
49–72 of 107
Search insights Median review: 95d Cleared: 99% Top manufacturer: Philips Medical Systems Nederland B.V. Lead specialty: Radiology
Cleared Jan 24, 2020
IQon Spectral CT
K193454 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 42d
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