Philips Medical Systems Nederland B.V.

FDA Device Registration & Listing · Eindhoven Noord-Brabant, NL · Registration 3000976525

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3000976525
FEI Number
3000976525
Entity Name
Philips Medical Systems Nederland B.V.
City/State/Country
Eindhoven Noord-Brabant, NL
Establishment Address
High Tech Campus 36, Eindhoven Noord-Brabant 5656 AE, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Philips Medical Systems International BV (Owner Number: 1217116)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241659
PMA Number
N/A

All Registered Proprietary Names

TOMTEC-ARENA Xper Information Management System Xper Flex Cardio Physiomonitoring System IntelliSpace Cardiovascular Xcelera CSMC Cardiac Suite AutoQuant Philips Hemodynamic Application R1 Ultrasound Workspace

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-01-19
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-01-19
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2011-06-29
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2011-06-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2009-09-03
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2020-12-07
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2018-09-11
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-03-19
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-03-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Pedroza Business: Philips Email: martin.pedroza@philips.com Phone: (440) 2197243

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
K163715 Philips Medical Systems Nederland B.V. Allura Xper R9 2017-01-26
K243871 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 5.1 2025-03-06
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000976525. Last updated year: 2026. Please use registration number 3000976525 when referencing this establishment in official correspondence.
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