Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013599033

FEI Number

3013599033

Entity Name

BONTECH CO., LTD

City/State/Country

Suwon-si Gyeonggi, KR

Establishment Address

Digital Empire D #1201,16, Deogyeong-daero,1556 beon-gil, Youngtong-gu Youngtong-dong 980-3, Suwon-si Gyeonggi 443702, KR

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Bontech Co., Ltd (Owner Number: 10062226)

Owner / Operator Contact Address

Digital Empire D #1201,16, Deogyeong-daero,1556 beon-gil, Youngtong-gu Youngtong-dong 980-3, Suwon-si, KR-41 443702, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171485

PMA Number

N/A

All Registered Proprietary Names

BSD3543W BT-DB22W (Gdos) BT-DA22W (CsI) BSD4343R Digital Flat Panel X-ray Detector BT-DB24-IA(Gdos) BT-DA24-IA(CsI) BSD4343R

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	2020-05-17
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-12-30

Official Correspondent

Dave Kim

US Agent Details

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

Related Public Records

Same Entity

Bontech 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.

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 3013599033. Last updated year: 2026. Please use registration number 3013599033 when referencing this establishment in official correspondence.