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Shanghai Chenshi Medical Instruments Co., Ltd: FDA-registered device maker in Shanghai, China, 7 510(k) clearances

Name: Shanghai Chenshi Medical Instruments Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Chenshi Medical Instruments Co., Ltd is registered with the FDA (registration 3012439308) in Shanghai, China. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 28, 2010. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012439308
Address: Room, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District, Shanghai, China, 201700
Owner or operator: Shanghai Chenshi Medical Instruments Co., Ltd (10058646)
Roles: Exporter to the US
First device listed: October 17, 2018
Registered through: 2026
Brand names listed: Knee/Foot/Ankle Coil, multiple types, Pediatric Body-Cardiac Coil (4522-133-18721), Pediatric Body-Cardiac Coil (4522-150-41131), Pediatric Body-Cardiac Coil (Model: 5000012601), Pediatric Head-Spine Coil (4522-133-18981), Pediatric Head-Spine Coil (4522-150-41161), Pediatric Head-Spine Coil (Model: 5000012701), QUAD HEAD COIL 1.5T and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 28, 2010	K101949	PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
July 14, 2010	K101858	PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
June 18, 2008	K081340	PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
June 18, 2008	K081322	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
July 23, 2007	K071847	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
August 2, 2005	K052013	ACHIEVA 1.5T & INERA 1.5T FAMILY	LNH	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
February 15, 2005	K043147	ACHIEVA FAMILY	LNH	Substantially Equivalent	Philips Medical Systems North America Co.	accessdata.fda.gov

Compare with other makers

Updated July 28, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.