510(k) 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 by
Shenzhen RF Tech Co., Ltd.
— Product Code MOS
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2026
- Date Received
- September 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type