Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042175844

FEI Number

3042175844

Entity Name

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

City/State/Country

BEST Noord-Brabant, NL

Establishment Address

VEENPLUIS 6, BEST Noord-Brabant 5684 PC, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K031597

PMA Number

N/A

All Registered Proprietary Names

Veradius Neo Azurion 7 B20 Azurion 5 M12 Azurion 3 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 M20 Azurion 5 M20 Azurion 7 B12 Dynamic Coronary Roadmap 2 722058 - Allura Xper FD20/15 722039 - Allura Xper FD20/20 OR Table 722035 - Allura Xper FD20 OR Table 722059 - Allura Xper FD20/15 OR Table 722029 - Allura Xper FD20/10 722033 - Allura Xper FD10 OR Table 722026 - Allura Xper FD10 722036 - Allura Xper FD20/10 OR Table 722027 - Allura Xper FD10/10 722034 - Allura Xper FD10/10 OR Table 722028 - Allura Xper FD20 722038 - Allura Xper FD20/20 Geometric QA Phantom - 459800438932 Philips DoseAware R1.1 DoseAware R2 DoseAware AneurysmFlow Azurion R2 Collimator IITV Square Collimator FD12 Square Collimator FD15 Collimator P225 ACS Rev 1.1 Collimator BV300 NICOL Collimator Family Square Collimator FD17 Allura Xper FD10 Allura R9 ALLURA XPER FD20 SERIES ALLURA XPER FD BIPLANE SERIES ALLURA XPER FD OR TABLE SERIES ALLURA XPER FD10 SERIES Zenition 70 SmartCT CT TrueView - 001010 Heart Navigator Release 2 Allura Xper R9 Allura Xper OR Table Series Allura 3D-CA 3D-CA CT TrueView XperCT Rel. 3 ALLURA XPER FD BIPLANE SERIES Rel 8.2 ALLURA XPER FD OR TABLE SERIES Rel 8.2 ALLURA XPER FD20 SERIES Rel 8.2 ALLURA XPER FD10 SERIES Rel 8.2 VesselNavigator Interventional Workspot Integris Allura FD R1.2 (FD10) Allura Xper FD10/10 Veradius Unity XperGuide Zenition 90 Zenition 50 Allura Xper FD series and Allura Xper OR Table series Zenition 30 EchoNavigator R3 Veradius Philips Hemodynamic Application R1 001014 - 2D Quantitative Analysis Allura Xper FD Series Allura Xper OR Table Series Radiologic Table EchoNavigator R4 BV Pulsera BV Endura EchoNavigator R5 MR-CT Roadmap Rel. 1 Allura 3D-RA Rel. 6 3D Roadmap Rel. 1 3D-RA Allura Xper FD20 Allura Xper FD20/10 Allura Xper FD20/20 Zenition 70 FORMAT Collimator Family

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2015-01-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2015-01-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-01-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-05-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-05-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-11-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-11-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-08-03
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2010-06-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-02-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-02-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-08-08
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-08-08
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2019-03-27
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2006-02-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-03-17
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-03-17
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-10-15
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-10-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-10-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-02-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-02-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-02-12
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-08-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-23
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-11-29
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-11-29
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2010-08-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2010-08-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2006-02-21
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2006-02-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-10-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2015-10-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-11-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-11-15
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2009-04-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-10-31
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-10-31
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2014-10-31
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-11
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-05-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-05-24
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-05-24
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2019-03-27
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2019-03-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2019-03-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-12-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-02-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-02-20
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-02-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-04-14
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2009-04-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2009-04-24
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2018-09-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-08-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-11-07
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-11-07
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2006-02-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-07-12
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2006-02-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2006-02-21
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2006-02-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-03-19
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-03-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-06-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-06-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2009-04-22
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2009-04-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2009-04-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2019-03-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2019-03-27
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2019-03-27
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2006-02-21
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2006-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Email: maria.heiling@philips.com Phone: (858) 2487651

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K060344	Breakaway Imaging, LLC	O-ARM IMAGING SYSTEM	2006-03-29
K982706	Philips Medical Systems, Inc.	PHILIPS BV300 SERIES RELEASE 2.1	1998-09-02
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042175844. Last updated year: 2026. Please use registration number 3042175844 when referencing this establishment in official correspondence.