Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015763655

FEI Number

3015763655

Entity Name

Philips Medical Systems Technologies Ltd.

City/State/Country

Haifa, IL

Establishment Address

MATAM, Building 34, Haifa 3100202, IL

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

Expiration Date (Year)

2026

510(k) Number

K172609

PMA Number

N/A

All Registered Proprietary Names

AV Viewer XD3 StrokeViewer LVO Triaging CAAS MR Solutions (4D Flow and Strain) NeuroQuant ClearRead CT XV LVAS XV Lung Ventilation Analysis Software System Corridor4DM LDA Lung Density Analysis NeuroQ CT:VQ ECTb IntelliSpace Portal V12.x Advanced Visualization Workspace V15.X CT Lung Ventilation Analysis Software CT LVAS XD XD4 Illumeo v2.x Illumeo CSMC Cardiac Suite AutoQuant

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	2025-12-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-18
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-04-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-04-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-18
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2023-01-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-04-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-01-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-01-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-04-21
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-01-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-02-02
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-01-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-11-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-04-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-04-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-03-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-03-21
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-12-07

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
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
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

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 3015763655. Last updated year: 2026. Please use registration number 3015763655 when referencing this establishment in official correspondence.