Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006239787

FEI Number

3006239787

Entity Name

SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

City/State/Country

SHANGHAI, CN

Establishment Address

No. 1269, Huaqing Road, Qingpu District, SHANGHAI 201707, CN

Establishment Type(s)

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

Owner / Operator

SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO., LTD. (Owner Number: 9093889)

Owner / Operator Contact Address

No. 1269, Huaqing Road, Qingpu District, SHANGHAI, CN-SH 201707, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101858

PMA Number

N/A

All Registered Proprietary Names

dS Pediatric Head-Spine Coil 1.5T 8ch (4598-000-2068X) SENSE SPINE COIL 1.5T ODU 4522-133-1724X SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-000-5189X QUAD HEAD COIL T/R 1.5T 4598-002-0529X SENSE CARDIAC COIL 1.5T ODU 4522-133-1726X QUAD HEAD COIL 1.5T 4522-133-1727X SENSE FLEX M COIL 1.5T ODU 4522-133-1717X dS Pediatric Torso-Cardiac Coil 3T 8ch (4598-000-2065X) Knee/Foot/Ankle Coil (4522-150-4097X) SENSE FLEX M COIL 3T ODU 4522-133-1721X QUAD HEAD COIL T/R 3T 4598-001-5223X dS Pediatric Head-Spine Coil 3T 8ch (4598-000-2066X)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2008-06-21
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-08-12
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2010-12-14
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2007-08-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-02-20
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2010-12-14

Official Correspondent

Jie Huang

US Agent Details

CHARLES MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES 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
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

Similar Registrations

Registration Number	Establishment Name	Location
3012169560	SIARON MEDICAL LTD	Vancouver British Columbia, CA
3009077524	DHL SUPPLY CHAIN (NETHERLANDS) B.V.	Beringe Limburg, NL
3010949642	GE HEALTHCARE (TIANJIN) COMPANY LIMITED	Tianjin, CN
3006369484	NEOCOIL, LLC	Pewaukee, WI, US
3010703925	MAKAR CONSULTING PTY LTD	Belrose New South Wales, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006239787. Last updated year: 2026. Please use registration number 3006239787 when referencing this establishment in official correspondence.