Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005560996

FEI Number

3005560996

Entity Name

RADLINK, INC.

City/State/Country

El Segundo, CA, US

Establishment Address

2101 E El Segundo Blvd, Suite 104, El Segundo, CA 90245, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

RADLINK, INC. (Owner Number: 9048903)

Owner / Operator Contact Address

2101 E El Segundo Blvd, Suite 104, --, El Segundo, CA 90245, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161966

PMA Number

N/A

All Registered Proprietary Names

Radlink WCA Kit Radlink Bucky Cart Radlink GPS Tablet Radlink Wireless C-Arm Kit Radlink Pro Imaging Software Radlink Surgeon's Checklist Software Radlink PACS Radlink DR Pro Radlink Galileo Positioning System Radlink GPS Radlink digital radiography system Radlink OR Pro Galileo Positioning System (GPS) Radlink digital radiography system Galileo Positioning System (GPS) Radlink OR Pro PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector

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	2015-12-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-06-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-06-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-10-07

Official Correspondent

THOMAS HACKING

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RADLINK, INC.

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

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.

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 3005560996. Last updated year: 2026. Please use registration number 3005560996 when referencing this establishment in official correspondence.