Data / Medical devices / China / Shenzhen RF Tech Co., Ltd.
Shenzhen RF Tech Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 12 510(k) clearances
Shenzhen RF Tech Co., Ltd. is registered with the FDA (registration 3009755250) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009755250
- Address
- 601,602 of BLD1, Guangming Digital Intelligent Manufacturing Industrial Park,18th Xialang Road Gongming, Guangming district, Shenzhen Guangdong, China, 518106
- Owner or operator
- Shenzhen RF Tech Co., Ltd. (10049868)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 18, 2015
- Registered through
- 2027
- Brand names listed
- 1.5T 24E Posterior Array 10-F28808, 1.5T HD T/R Knee Array/10-F34127, 10-F34722/HD 8Ch Wrist Array, 10-F34742/GEM Flex Coil 16-M Array, 3T Receive Only, 10-F34743/GEM Flex Coil 16-S Array, 3T Receive Only, 10-F34744/GEM Flex Coil 16-L Array, 3T Receive Only, 10-F35780/GEM Flex Coil 16-L Array, 1.5T Receive Only, 10-F35781/GEM Flex Coil 16-M Array, 1.5T Receive Only and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 14, 2026 | K252587 | HD 8Ch Wrist Array | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| April 1, 2026 | K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| February 10, 2026 | K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| August 18, 2023 | K231085 | 1.5T HD T/R Knee Array (10-F34127) | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| March 2, 2023 | K223203 | 1.5T 24E Posterior Array | LNH | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| February 14, 2023 | K223225 | 8ch T/R Knee Coil | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| December 8, 2022 | K223239 | 8ch Wrist Coil | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| July 22, 2020 | K200836 | 8ch Flex Suite | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| December 8, 2017 | K172222 | 8ch Flex Suite | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| August 1, 2016 | K160932 | 8ch Foot Ankle Coil | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| July 28, 2016 | K160935 | 8ch Foot Ankle Coil | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
| August 7, 2015 | K151653 | 8ch Foot Ankle Coil | MOS | Substantially Equivalent | Shenzhen RF Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
Updated April 14, 2026. 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.