GEM Flex Coil 16-L Array, 1.5T Receive Only +2 more— 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 +2 more, Substantially Equivalent on 2026-02-10. Applicant: Shenzhen RF Tech Co., Ltd.. Device class: 2.
Summary
Shenzhen RF Tech lists three GEM Flex Coil entries, the 16-L, 16-M, and 16-S Array, each marked "1.5T Receive Only." They're filed under product code MOS (Coil, Magnetic Resonance, Specialty), and the record doesn't say how they differ beyond those names.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shenzhen RF Tech filed from Shenzhen, China. FDA found it substantially equivalent 214 calendar days after receipt (July 11, 2025 to February 10, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- Shenzhen RF Tech Co., Ltd.
- Product code
- Product 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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More clearances from Shenzhen RF Tech Co., Ltd.
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