K243316
- 510(k) number
- K243316
- Device name
- XENOVIEW 3.0T Chest Coil
- Applicant
- Polarean, Inc. NC · US
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2024-11-19
- Date received
- 2024-10-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243316.pdf
Official FDA record: K243316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.