Data / Medical devices / China / Shanghai Chenguang Medical Technologies Co, Ltd
Shanghai Chenguang Medical Technologies Co, Ltd: FDA-registered device maker in Shanghai, China, 5 510(k) clearances
Shanghai Chenguang Medical Technologies Co, Ltd is registered with the FDA (registration 3006239787) in Shanghai, China. It lists 2 device types. The FDA files 5 510(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
- 3006239787
- Address
- No. 1269, Huaqing Road Qingpu District, Shanghai, China, 201707
- Owner or operator
- SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO., LTD. (9093889)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 9, 2007
- Registered through
- 2026
- Brand names listed
- Knee/Foot/Ankle Coil (4522-150-4097X), MICROSCOPY 23MM COIL 1.5T, QUAD HEAD COIL 1.5T 4522-133-1727X, QUAD HEAD COIL T/R 1.5T 4598-002-0529X, QUAD HEAD COIL T/R 3T 4598-001-5223X, SENSE CARDIAC COIL 1.5T ODU 4522-133-1726X, SENSE FLEX M COIL 1.5T ODU 4522-133-1717X, SENSE FLEX M COIL 3T ODU 4522-133-1721X and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Contract manufacturer | 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 |
Compare with other makers
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Nuclear Magnetic Resonance Imaging
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.