Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2433615

FEI Number

2433615

Entity Name

MEDLINK IMAGING, LLC.

City/State/Country

Pine Brook, NJ, US

Establishment Address

1 CHAPIN RD STE 3, Pine Brook, NJ 07058, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MEDLINK IMAGING (Owner Number: 2433615)

Owner / Operator Contact Address

1 CHAPIN ROAD, UNIT 3, --, Pine Brook, NJ 07058, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170607

PMA Number

N/A

All Registered Proprietary Names

VIVIX-S DR FW Series 4343 FAW Wireless Panel, VIVIX-S DR FW Series 4343 FAW-PLUS Wireless Panel VIVIX-S DR FW Series 2530 FAW Wireless Panel, VIVIX-S DR FW Series 2530 FAW-PLUS Wireless Panel VIVIX-S DR FW Series 3643 FAW Wireless Panel, VIVIX-S DR FW Series 3643 FAW-PLUS Wireless Panel VIVIX-S DR 1717N Cassette Size Tethered Panel VIVIX-S DR 1717N Cassette Size Wireless Panel VIVIX-S 1751S VIVIX-S DR 1012N Wireless Panel VIVIX-S DR Panel Medlink Rover Medlink FDR, Medlink FDR-PLUS, Medlink SDR, Medlink SDR-PLUS, Medlink CDR VIVIX-S DR VW Series 1417VW-PLUS Wireless Panel VIVIX-S DR VW Series 1012VW-PLUS Wireless Panel VIVIX-S DR VW Series Wireless Panel VIVIX-S DR VW Series 1717VW Wireless Panel VIVIX-S DR VW Series 1417VW Wireless Panel VIVIX-S DR VW Series 1717VW-PLUS Wireless Panel VIVIX-S DR VW Series 1012VW Wireless Panel QXLink VIVIX-M Medlink M1 Mobile X-Ray System Medlink JADE Mobile Solution Medlink JADE Portable X-Ray System VIVIX-S DR 1417S Tethered Panel VIVIX-S DR 1717V Fixed Panel !M1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-12-06
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-08-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2026-02-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-07-01
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-04-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2023-01-04
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2023-01-04
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2022-12-06
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-12-06
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-12-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-12-21
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-03-03
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	1992-07-06
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2025-05-07
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2020-12-21
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-03-27
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2024-07-15

Official Correspondent

Brandon Cho

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDLINK IMAGING

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434

Similar Registrations

Registration Number	Establishment Name	Location
3016256852	KA IMAGING INC.	Waterloo Ontario, CA
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3038614464	Canon.Inc	OHTA-KU Tokyo, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2433615. Last updated year: 2026. Please use registration number 2433615 when referencing this establishment in official correspondence.