Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009755250

FEI Number

3009755250

Entity Name

Shenzhen RF Tech Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

601,602 of BLD1, Guangming Digital Intelligent Manufacturing Industrial Park,18th Xialang Road, Gongming, Guangming district, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Shenzhen RF Tech Co., Ltd. (Owner Number: 10049868)

Owner / Operator Contact Address

601,602 of BLD1, Guangming Digital Intelligent Manufacturing Industrial Park,18th Xialang Road, Gongming,Guangming district, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223239

PMA Number

N/A

All Registered Proprietary Names

8ch Foot Ankle Coil Model 10-F21457 10-F35781/GEM Flex Coil 16-M Array, 1.5T Receive Only 10-F35780/GEM Flex Coil 16-L Array, 1.5T Receive Only 10-F35782/GEM Flex Coil 16-S Array, 1.5T Receive Only 1.5T 24E Posterior Array 10-F28808 10-F34722/HD 8Ch Wrist Array 8ch Flex 70 Array Model 10-F24260 8ch Flex 40 Array Model 10-F24262 8ch Flex 50 Array Model 10-F24261 8ch Flex 40 Array 10-F25063 8ch Flex 70 Array 10-F25061 8ch Flex 50 Array 10-F25062 10-F34742/GEM Flex Coil 16-M Array, 3T Receive Only 10-F34744/GEM Flex Coil 16-L Array, 3T Receive Only 10-F34743/GEM Flex Coil 16-S Array, 3T Receive Only 1.5T HD T/R Knee Array/10-F34127 8ch Wrist Coil 10-F32119

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	2015-08-18
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-02-25
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-03-08
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-04-26
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2017-12-10
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-07-22
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-04-14
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-09-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2022-12-11

Official Correspondent

Wang Gary

US Agent Details

Ann Marie Boullie Business: Casus Consulting LLC Email: USAgent@casusconsulting.com Phone: (972) 5326357

Related Public Records

Same Entity

Shenzhen RF Tech 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 3009755250. Last updated year: 2026. Please use registration number 3009755250 when referencing this establishment in official correspondence.