Micro-X Ltd.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1669-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 ProdApril 4, 2025
Z-1670-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product DescripApril 4, 2025
Z-1578-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product DescriMarch 28, 2025
Z-1579-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product DescriMarch 28, 2025
Z-0666-2025Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV19October 23, 2024
Z-0580-2025Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV35October 22, 2024
Z-0665-2025Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71November 28, 2023
Z-0664-2025Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV35May 31, 2023
Z-1786-2022Class IIMICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19August 31, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K201488RoverJuly 17, 2020