Clearance Summary
HealthCCSng received FDA 510(k) clearance under submission number K241440, sponsored by Nano-X AI , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-08-19.
- Submission: K241440
- Applicant / Sponsor: Nano-X AI , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2024-08-19
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.