K252876
- 510(k) number
- K252876
- Device name
- 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. CN
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2026-04-01
- Date received
- 2025-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252876.pdf
Official FDA record: K252876
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.