Philips Medical Systems Nederland B.V.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

  2026-01-14

  Philips Medical Systems Nederland B.V.

• Philips IntelliSpace Cardiovascular

  2025-10-02

  Philips Medical Systems Nederland B.V.

• Philips iCT CT system

  2025-06-27

  Philips Medical Systems Nederland B.V.

• Philips IntelliSite Pathology Solution 5.1

  2024-12-10

  Philips Medical Systems Nederland B.V.

• Philips IntelliSite Pathology Solution

  2024-12-02

  Philips Medical Systems Nederland B.V.

• ROCC Console

  2024-10-24

  Philips Medical Systems Nederland B.V.

• dS Wrist coil 8ch 1.5T

  2024-10-18

  Philips Medical Systems Nederland B.V.

• dS Knee Coil 8ch 1.5T

  2024-10-18

  Philips Medical Systems Nederland B.V.

• dS FootAnkle Coil 8ch 1.5T

  2024-08-12

  Philips Medical Systems Nederland B.V.

• Philips IntelliSite Pathology Solution 5.1

  2024-06-24

  Philips Medical Systems Nederland B.V.

• LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

  2024-03-14

  Philips Medical Systems Nederland B.V.

• Zenition 30

  2024-02-16

  Philips Medical Systems Nederland B.V.

• Ingenia Elition R5.7.1 SP4 MR Systems

  2023-08-02

  Philips Medical Systems Nederland B.V.

• AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

  2023-06-08

  Philips Medical Systems Nederland B.V.

• Ingenia Elition and MR 7700 MR Systems

  2023-04-28

  Philips Medical Systems Nederland B.V.

• Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems

  2023-04-06

  Philips Medical Systems Nederland B.V.

• EchoNavigator R4.0

  2022-05-31

  Philips Medical Systems Nederland B.V.

• Achieva, Ingenia, Ingenia CX, Ingenia Elition And Ingenia Ambition MR Systems

  2022-05-16

  Philips Medical Systems Nederland B.V.

• Spectral CT On Rails

  2022-05-13

  Philips Medical Systems Nederland B.V.

• MR 5300

  2021-11-19

  Philips Medical Systems Nederland B.V.

• Philips IntelliSite Pathology Solution

  2021-09-17

  Philips Medical Systems Nederland B.V.

• Brain Perfusion (BP) application

  2021-08-17

  Philips Medical Systems Nederland B.V.

• Vereos PET/CT

  2021-08-06

  Philips Medical Systems Nederland B.V.

• Vereos PET/CT

  2021-05-19

  Philips Medical Systems Nederland B.V.

• Spectral CT

  2021-02-26

  Philips Medical Systems Nederland B.V.

• The Multimodality Advanced Vessel Analysis

  2020-11-25

  Philips Medical Systems Nederland B.V.

• Stimuplex Onvision System

  2020-05-27

  Philips Medical Systems Nederland B.V.

• EchoNavigator

  2020-04-09

  Philips Medical Systems Nederland B.V.

• Achieva 1.5T, 3.0T And Intera 1.5T MR Systems

  2019-06-04

  Philips Medical Systems Nederland B.V.

• Brain Perfusion (BP) Application

  2019-05-29

  Philips Medical Systems Nederland B.V.

• Ingenia, Ingenia CX, Ingenia Elition, And Ingenia Ambition MR Systems

  2019-02-14

  Philips Medical Systems Nederland B.V.

• KODEX EPD System

  2018-10-24

  Philips Medical Systems Nederland B.V.

• Ingenia Ambition S And Ingenia Ambition X

  2018-08-03

  Philips Medical Systems Nederland B.V.

• Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4

  2018-04-04

  Philips Medical Systems Nederland B.V.

• Ingenia Elition S And Ingenia Elition X

  2018-03-20

  Philips Medical Systems Nederland B.V.

• Ingenia Elition S And Ingenia Elition X R5.4

  2018-03-06

  Philips Medical Systems Nederland B.V.

• 3D APT

  2018-01-22

  Philips Medical Systems Nederland B.V.

• Advanced Diffusion Analysis (ADA) Application

  2017-12-12

  Philips Medical Systems Nederland B.V.

• Dynamic Coronary Roadmap 2.0

  2017-10-24

  Philips Medical Systems Nederland B.V.

• Philips IntelliSite Pathology Solution

  2017-10-04

  Philips Medical Systems Nederland B.V.

70 records. Showing 1-40. Next

GUDID#

• SmartCT - Software medical device, used with a Philips Interventional X-Ray System. Assists physicians by providing 3D views of the anatomy combined with planning and life guidance functionality.

  Philips Medical Systems Nederland B.V.

  2026-09-28

• Radiology Operations Command Center Console - 1

  Philips Medical Systems Nederland B.V.

  2025-03-14

• EchoNavigator - Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.

  Philips Medical Systems Nederland B.V.

  2026-03-25

• Image Management - Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.

  Philips Medical Systems Nederland B.V.

  2024-11-15

• Desktop Diagnostic Viewer - The Desktop Diagnostic Viewer is the end user’s primary user interface used to interact with clinical images. It includes the clinical applications.

  Philips Medical Systems Nederland B.V.

  2024-11-15

• Web Diagnostic Viewer - The Web Diagnostic Viewer is the radiologist diagnostic workstation including the clinical applications (implemented using Web technology) with similar functionality as the Desktop Diagnostic Viewer workstation.

  Philips Medical Systems Nederland B.V.

  2024-11-15

• Enterprise Viewer - The Enterprise Viewer is used for image distribution within the enterprise. It is used by clinicians as the primary user interface to view and interact with images. It is also used by Radiologists as a lightweight form to access images where they don’t have access to the complete diagnostic workstations. Enterprise Viewer is accessed through an HTML5 browser either over a desktop or using a capable mobile device.

  Philips Medical Systems Nederland B.V.

  2024-11-15

• Dynamic Coronary Roadmap - Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.

  Philips Medical Systems Nederland B.V.

  2020-11-10

• StentBoost Live - Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents.

  Philips Medical Systems Nederland B.V.

  2020-11-10

• EchoNavigator - Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.

  Philips Medical Systems Nederland B.V.

  2023-02-10

• Vue PACS (Web Diagnostic) - The Vue PACS (Web Diagnostic) viewer is an add-on capability that allows running the diagnostic viewer capabilities from a web browser.

  Philips Medical Systems Nederland B.V.

  2021-06-03

• SmartCT - Software medical device, used with a Philips Interventional X-Ray System. Assists physicians by providing 3D views of the anatomy combined with planning and life guidance functionality.

  Philips Medical Systems Nederland B.V.

  2021-02-25

• Onvision system - Intended to be used during peripheral nerve block procedures. Tracks the position of the B.Braun Onvision needle tip position on the ultrasound image by overlaying a circle at the given location.

  Philips Medical Systems Nederland B.V.

  2020-08-07

• Vue PACS - The Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system is to be used by trained professionals including, but not limited to, physicians and medical technicians.

  Philips Medical Systems Nederland B.V.

  2020-05-18

• Vue PACS (Diagnostic) - The Vue PACS diagnostic client is web deployable and has a variety of user profiles applicable to different stakeholder in the cycle of care such as radiologists, referring physicians, technologists etc. With advanced streaming technology, the Vue PACS diagnostic client can perform well even over slow communication lines between the client and the server. Enterprise workflow capabilities allow users across the network to read and report from a global worklist, irrespective of the image acquisition location. The Vue Diagnostic workstation includes native clinical applications such as Lesion Management, CT Perfusion, MR Perfusion/Diffusion.

  Philips Medical Systems Nederland B.V.

  2020-05-18

• Vue Motion - The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.

  Philips Medical Systems Nederland B.V.

  2020-05-18

• EP navigator - Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• Interventional Workspot - Software medical device hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• HeartNavigator - Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• 3D Roadmap - Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Superimposes live fluoroscopic images on a 3D reconstruction of the vessel anatomy.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• MR-CT Roadmap - Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• Allura 3D-CA - Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• XperGuide - Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Intended to assist the user during percutaneous interventions by providing live 3D needle image guidance.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• StentBoost - Software medical device, used with a Philips Interventional X-Ray System. Provides high resolution visualization of stents in vessels. Supports the user in placing and deploying stents.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• 2D Perfusion - Software medical device, used with a Philips Interventional X-Ray System. Provides a color coded representation of a digital subtraction angiography (DSA).

  Philips Medical Systems Nederland B.V.

  2016-09-24

• EchoNavigator - Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• EmboGuide - Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Assists physicians with embolization of hypervascular tumors in the liver using interventional X-ray.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• XperCT Dual - Software medical device, used with a Philips Interventional X-Ray System. Reconstructs 3D volumes from rotational fluoroscopic acquisitions and provides CT-like images to assist the physician.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• AneurysmFlow - Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes.

  Philips Medical Systems Nederland B.V.

  2017-03-03

• VesselNavigator - Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• CT Trueview - Software medical device, used with a Philips Interventional X-Ray System. Creates a CT based 3D model of the coronary vessel tree. Provides a composite image of 2D X-ray exposure image and 3D model.

  Philips Medical Systems Nederland B.V.

  2017-01-19

• 2D Quantitative Analysis - Software medical device, used with a Philips Interventional X-Ray System. Provides quantitative information about coronary arteries, peripheral arteries, and ventricles.

  Philips Medical Systems Nederland B.V.

  2017-02-20

• EchoNavigator - Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.

  Philips Medical Systems Nederland B.V.

  2017-09-13

• HeartNavigator - Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.

  Philips Medical Systems Nederland B.V.

  2016-11-30

• Dynamic Coronary Roadmap - Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.

  Philips Medical Systems Nederland B.V.

  2017-06-29

• StentBoost Live - Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents.

  Philips Medical Systems Nederland B.V.

  2017-06-29

• ViewForum - ViewForum is an image processing workstation software package designed to run on standard PC hardware that performs viewing, image manipulation, communication, printing, and quantification of images.

  Philips Medical Systems Nederland B.V.

  2016-09-24

• 3D-RA - Software medical device, used with a Philips Interventional X-Ray System. Creates 3D views of vessels and bones from sets of 2D images from rotational angiographic runs.

  Philips Medical Systems Nederland B.V.

  2017-03-28

• 3D-CA - Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.

  Philips Medical Systems Nederland B.V.

  2017-03-28

• Dynamic Coronary Roadmap - Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.

  Philips Medical Systems Nederland B.V.

  2017-11-07

200 records. Showing 1-40. Next