Clearance Summary
Rover received FDA 510(k) clearance under submission number K211423, sponsored by Micro-X Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-05-21.
- Submission: K211423
- Applicant / Sponsor: Micro-X Limited
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2021-05-21
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.