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— 510(k) K252179
Substantially EquivalentShenzhen RF Tech Co., Ltd.
FDA 510(k) clearance K252179 for 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, Substantially Equivalent on 2026-02-10. Applicant: Shenzhen RF Tech Co., Ltd..
Clearance details
- Applicant
- Shenzhen RF Tech Co., Ltd.
- Product code
- Code MOS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.