Clearance Summary
Rover received FDA 510(k) clearance under submission number K201488, sponsored by Micro-X , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-07-17.
- Submission: K201488
- Applicant / Sponsor: Micro-X , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2020-07-17
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.