Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012439308

FEI Number

3012439308

Entity Name

SHANGHAI CHENSHI MEDICAL INSTRUMENTS CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

Room 206-207, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District, Shanghai 201700, CN

Establishment Type(s)

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

Owner / Operator

Shanghai Chenshi Medical Instruments Co., Ltd (Owner Number: 10058646)

Owner / Operator Contact Address

Room 206-207, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District, Shanghai, CN-SH 201700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052013

PMA Number

N/A

All Registered Proprietary Names

QUAD HEAD COIL 1.5T SENSE FLEX S COIL 1.5T ODU SENSE FLEX L COIL 3T ODU SYN.BODY COIL 1.5T ODU SENSE CARDIAC COIL SENSE FLEX M COIL 3T ODU SENSE FLEX M COIL 1.5T ODU SYN.BODY COIL 1.5T ODU WITH SLEEVE SENSE FLEX L COIL 1.5T ODU SENSE FLEX S COIL 3T ODU SYN.BODY COIL 1.5T WITH SLEEVE SENSE SPINE COIL 1.5T SHNC DRIVERBOX 1.5T ODU QUAD HEAD COIL T/R 1.5T SHNC DRIVERBOX 1.5T SENSE SPINE COIL 1.5T ODU

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-10-17

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shanghai Chenshi Medical Instruments 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
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0392-2024	Philips North America Llc	2	Ingenia 1.5T CX
Z-0393-2024	Philips North America Llc	2	Intera 1.5T
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.

Similar Registrations

Registration Number	Establishment Name	Location
3019844073	TracInnovations A/S	Ballerup Hovedstaden, DK
3012169560	SIARON MEDICAL LTD	Vancouver British Columbia, CA
3033536331	NEOSCAN SOLUTIONS GMBH	Magdeburg Saxony-Anhalt, DE
3020162557	SPINTECH, INC.	Bingham Farms, MI, US
3012354318	JIANGSU MAGSPIN INSTRUMENT CO., LTD	Kunshan Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012439308. Last updated year: 2026. Please use registration number 3012439308 when referencing this establishment in official correspondence.