Micro-X Rover
Micro-X Rover (MXU-RV01) is a Class II device made by Micro-X, Ltd., cleared under FDA 510(k) K201488 on 17 Jul 2020 and listed in FDA GUDID since 31 Aug 2020 (UDI-DI 00935712300004), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00935712300004 | Date31 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201488 | Date17 Jul 2020 | StatusActive |
Official records
- AccessGUDID record 00935712300004
- FDA 510(k) database K201488
Across registries
- FDA 510(k) K201488 decided 17 Jul 2020 Active
- FDA GUDID UDI-DI 00935712300004 listed 31 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K201488
- Listed FDA GUDID 00935712300004
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Micro-X
- Generic name
- Mobile basic diagnostic x-ray system, digital
- Model / Ref / Catalog
- Rover, MXU-RV01
- Primary DI / UDI-DI
- 00935712300004
- 510(k) Number
- FDA product code
- IZL, MQB
- GMDN term
- Mobile basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1720, 892.1680
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Mobile basic diagnostic x-ray system, digital.