Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017004860

FEI Number

3017004860

Entity Name

RADISEN CO LTD

City/State/Country

Anyang Gyeonggi, KR

Establishment Address

B-602, Hifield Building, 66, Beolmal-ro, Dongan-gu, Anyang Gyeonggi 14058, KR

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Radisen Co Ltd (Owner Number: 10079944)

Owner / Operator Contact Address

B-602, Hifield Buiding, 66, Beolmal-ro, Dongan-gu, Anyang, KR-41 14058, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180989

PMA Number

N/A

All Registered Proprietary Names

PEDRA-17F Digital Flat Panel X-ray Detector PEDRA-17FC Digital Flat Panel X-ray Detector PEDRA-17FG Digital Flat Panel X-ray 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	2021-01-05

Official Correspondent

No official correspondent registered.

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

Radisen Co Ltd

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.

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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 3017004860. Last updated year: 2026. Please use registration number 3017004860 when referencing this establishment in official correspondence.