Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023385454

FEI Number

3023385454

Entity Name

Philips DS North America LLC

City/State/Country

Gainesville, FL, US

Establishment Address

3630 SW 47th Avenue, Gainesville, FL 32608, US

Establishment Type(s)

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

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

K153073

PMA Number

N/A

All Registered Proprietary Names

UroNav 3 784027, DynaCAD UroNav UroNav 4 INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly GEMS and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly PHC and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, HITACHI INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly Skyra, SHC Needle Sleeve 16G Sentinelle, Biopsy Grid 459801508642 Breast Grid (User-Sterilized) 989603209144 Lateral Grid dS Breast 16CH I/T Breast Grid (User-Sterilized) 989603203484 MRI Needle Block 18G Pillar Immobilization Plate Pillar Immobilization Plate LBS M-L Lateral Grid, Lower dS Breast 16CH I/T Lateral Grid, Upper dS Breast 16CH I/T Needle Sleeve 18G 989603203464 MRI Needle Block 12G 989603203584 Mammotome Immobilization Plate 989603209104 Pillar Immobilization Plate Fiducial Marker Grid Block Assembly Needle Sleeve 12G Fiducial Holder Needle Sleeve 14G 989603203594 OBC Grid Immobilization Plate 989603214204 Biospy Grid, Sterilized Pillar Immobilization Plate BBC Needle Block, 16G 989603209064 Grid Immobilization Plate LBS MRI Needle Block 8G Needle Block, 12G Pillar Immobilization Plate LBS C-C Fiducial Marker Sleeve Assembly Needle Block Holder MRI Needle Sleeve 12G Pillar Immobilization Plate BBC Grid Immobilization Plate LBS C-C Grid Plate, Enhanced Access Lateral Grid Immobilization Plate LBS M-L Medial Grid dS Breast 16CH 1/T 459801507722 Biospy Grid, Sterilized 989603203474MRI Needle Block 14G Grid Plate, Enhanced Access Medial 989603203574 Pillar Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly SMS and Clamp Stand 989603203524 Grid Immobilization Plate Needle Hub Assembly 989603204304 MRI Needle Block 16G INVIVO (FLORIDA, USA): DynaTRIM Complete, HITACHI DynaTRIM Grid Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, GEMS Biopsy Grid Needle Block, 14G INVIVO (FLORIDA, USA): DynaTRIM Complete, Skyra Baseplate assembly SHC and Clamp Stand Grid Immobilization Plate BBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, SMS Needle Block, 18G Lateral Grid dS Breast 16CH 1/T INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, PHC INVIVO (FLORIDA, USA): DynaTRIM Clamp stand assembly INVIVO (FLORIDA, USA): DynaTRIM Complete, GEMS DynaTRIM DynaCAD DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) UroNav Fusion Biopsy System

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	2018-10-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-09-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-01-06
QTZ	Radiological Image Processing Software For Ablation Therapy Planning And Evaluation	Radiology	Class 2	892.2050	2025-06-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-06-10
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-11-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-08-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-03-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-02-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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 3023385454. Last updated year: 2026. Please use registration number 3023385454 when referencing this establishment in official correspondence.