Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007809729

FEI Number

3007809729

Entity Name

CORETRONIC PROJECTION (KUNSHAN) CORPORATION

City/State/Country

Kunshan Jiangsu, CN

Establishment Address

No. 20,3rd Ave, Kunshan Free Trade Zone, Kunshan Jiangsu 215300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Coretronic Projection (kunshan) Corporation (Owner Number: 10057805)

Owner / Operator Contact Address

No. 20,3rd Ave, Kunshan Free Trade Zone, Kunshan, CN-JS 215300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ENDOVUE, LifeVue, Radiance MDNC-2221 MH3281A; MH3281A-P; MH3281A-W; MH3281A-J; MH3281A-R; MH3281A-E

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2018-05-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-08-14
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2018-08-14

Official Correspondent

Cindy Li

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Coretronic Projection (kunshan) Corporation

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
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)

Similar Registrations

Registration Number	Establishment Name	Location
3010349493	PROMATE SOLUTIONS	Taipei, TW
3035371773	Rocoto Inc.	Irvine, CA, US
3038951686	BROADATA COMMUNICATIONS INC.	Torrance, CA, US
3008648418	ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD.	Zhengzhou Henan, CN
8043933	BRAINLAB SE	Munich Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007809729. Last updated year: 2026. Please use registration number 3007809729 when referencing this establishment in official correspondence.