K260947
- 510(k) number
- K260947
- Device name
- 0.55T 12Ch Breast Coil
- Applicant
- Neocoil, LLC WI · US
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2026-04-23
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260947.pdf
Official FDA record: K260947
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.