510(k) K252876 ยท MOS Coil, Magnetic Resonance, Specialty
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., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 1, 2026 |
| Received | Sep 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252876
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.