GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more— 510(k) K252876
Substantially EquivalentShenzhen RF Tech Co., Ltd.
FDA 510(k) clearance K252876 for GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more, Substantially Equivalent on 2026-04-01. Applicant: Shenzhen RF Tech Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- Shenzhen RF Tech Co., Ltd.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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