Clearance Summary
HealthOST received FDA 510(k) clearance under submission number K213944, sponsored by Nanoxai , 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 2022-04-22.
- Submission: K213944
- Applicant / Sponsor: Nanoxai , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2022-04-22
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.