Clearance Summary
iLoop Interventional Coil 0.55T received FDA 510(k) clearance under submission number K241069, sponsored by Noras Mri Products GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-06-07.
- Submission: K241069
- Applicant / Sponsor: Noras Mri Products GmbH
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2024-06-07
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.