K241069
- 510(k) number
- K241069
- Device name
- iLoop Interventional Coil 0.55T
- Applicant
- Noras Mri Products GmbH DE
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2024-06-07
- Date received
- 2024-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241069.pdf
Official FDA record: K241069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.