Clearance Summary
Nanox.ARC received FDA 510(k) clearance under submission number K242395, sponsored by Nano-X Imaging , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-12-04.
- Submission: K242395
- Applicant / Sponsor: Nano-X Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1740
- Decision date: 2024-12-04
Classification & Regulation
This clearance is catalogued under FDA product code IZF and 21 CFR 892.1740, within the Radiology review panel as a Class II device.