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Philips Medical Systems Nederland B.V.

Netherlands·NL-MF-000001489

Last updated September 17, 2026

What Philips Medical Systems Nederland B.V. makes

Philips Medical Systems Nederland B.V. manufactures radio-frequency coils for MRI systems, including dedicated body and spine coils, as well as full-body MRI systems with superconducting magnets. Their portfolio includes digital stationary and angiographic X-ray systems, along with associated software applications for imaging and workflow management. They also produce radiology picture archiving and communication system (PACS) workstations and software, patient health record systems, and single-use needle guides. Additionally, they supply pathology scanners for in vitro diagnostic (IVD) use and simulation workspaces for multimodal imaging planning.

The company’s devices are regulated under EU Medical Device Regulations (Class A, I, IIa, IIb) and are listed in the EUDAMED database, with some products also recorded in the FDA’s 510(k) and UDI registries. The manufacturer is based in the Netherlands.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Netherlands
Address: 6, Veenpluis, Best, Netherlands
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: —
EUDAMED SRN: NL-MF-000001489
FDA FEI Number: 3002807880
DUNS Number: —

Catalogue (698)

Page 4 of 14

Device	Model / Reference	Registries	Class	Status
IntelliSpace Cardiovascular	IntelliSpace Cardiovascular 1.2	FDA UDI	Class II	Active
Xper Information Management System	2.2	FDA UDI	Class II	Active
Allura Xper FD	Allura Xper R9 7 M12	FDA UDI	Class II	Unknown
Ingenia	Ingenia 3.0T	FDA UDI	Class II	Active
Vue PACS (Diagnostic)	Vue PACS (Diagnostic) - 12	FDA UDI	Class II	Active
Allura Xper FD	Allura Xper FD20 Biplane	FDA UDI	Class II	Active
ClarifEye	ClarifEye - 1	FDA UDI	Class II	Active
Xper Information Management System	2.6	FDA UDI	Class II	Active
Enterprise Viewer	15.X	FDA UDI	Class II	Active
Advanced Visualization Workspace	Advanced Visualization Workspace - 15	FDA UDI	Class II	Active
Illumeo	v2.2	FDA UDI	Class II	Active
Ingenia 1.5T S	781347	FDA UDI	Class II	Active
Dunlee Sentinelle	989603217881	FDA UDI	Class II	Active
Allura Xper FD	Allura Xper FD20 Biplane OR Table	FDA UDI	Class II	Active
Allura Xper FD	Allura Xper FD20/20 OR Table	FDA UDI	Class II	Active
Ingenia	Smartpath to dStream for 1.5T	FDA UDI	Class II	Active
Brilliance CT Big Bore	Brilliance CT Big Bore	FDA UDI	Class II	Active
Dunlee Sentinelle	989603218261	FDA UDI	Class II	Active
Desktop Diagnostic Viewer	15.X	FDA UDI	Class II	Active
Dunlee Sentinelle	989603217251	FDA UDI	Class II	Active
ST Multi-Purpose S Coil	45100004156*	FDA UDI	Class II	Active
Dunelee Sentinelle	989603216941	FDA UDI	Class II	Active
Dunlee Sentinelle	989603217341	FDA UDI	Class II	Active
Ingenia Ambition S and Ingenia Ambition X	K181479	FDA 510(k)	Class II	Active
Ingenia 1.5T and Ingenia 1.5T S R5.2	K153324	FDA 510(k)	Class II	Active
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	K163116	FDA 510(k)	Class II	Active
EchoNavigator	K200713	FDA 510(k)	Class II	Active
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4	K173079	FDA 510(k)	Class II	Active
Ingenuity CT System Upgrade	728327	EUDAMEDFDA UDI	Class IIb	Active
HD 8Ch Wrist Array	300007446561	EUDAMEDFDA UDI	Class IIa	Active
8Ch Medial Coil Sen 3T	300006546171	EUDAMEDFDA UDI	Class IIa	Active
XperGuide laser tool	300011230531	EUDAMED	Class I	Active
dS Shoulder Coil 8ch 1.5T	459801730042	EUDAMED	Class IIa	Active
dS Headrest	459801804022	EUDAMEDFDA UDI	Class IIa	Active
4Ch Left Lateral Coil Sen 3T	300006546111	EUDAMEDFDA UDI	Class IIa	Active
MRI Needle Sleeve 14G	989603203504	EUDAMEDFDA UDI	Class I	Active
Upgrades dStream to R11	782142	EUDAMEDFDA UDI	Class IIb	Active
Azurion 7 B12	722235	EUDAMEDFDA UDI	Class IIb	Active
Lateral Single Loop Coil Left VGTT	300009326011	EUDAMEDFDA UDI	Class IIa	Active
Medial Plug VT	300009322071	EUDAMEDFDA UDI	Class IIa	Active
HD 8Ch WRIST ARRAY (Receive Only)	300007314091	EUDAMEDFDA UDI	Class IIa	Active
Interface Box Breast Coil Sen 3T	300006547881	EUDAMEDFDA UDI	Class IIa	Active
HA FlexTrak II	989710008732	EUDAMEDFDA UDI	Class I	Active
Neuro mattress for Azurion series 3	459801110286	EUDAMED	Class I	Active
MRI Needle Block 16G	989603204304	EUDAMEDFDA UDI	Class I	Active
dS Small Extremity 16Ch 1.5T	459801728793	EUDAMEDFDA UDI	Class IIa	Active
Ratchet Compressor	459800722203	EUDAMED	Class I	Active
Ingenuity CT	728326	EUDAMEDFDA UDI	Class IIb	Active
Medial Plug VT	300009321441	EUDAMEDFDA UDI	Class IIa	Active
1Ch Right Coil Element Sen 1.5T	300006547311	EUDAMEDFDA UDI	Class IIa	Active

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