Company ยท AU
Micro-X Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2021. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
10recalls (1 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IZL | System, X-Ray, Mobile | 12 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2026 | Micro-X Ltd. Rover Mobile X-ray System
Model/Catalog Number: MXU-RV35 and MXU-RV71 Open, Classified |
IZL | K211423 |
| Apr 24, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number:MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-containe Open, Classified |
IZL | K211423 |
| Apr 24, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71, MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a se Open, Classified |
IZL | K211423 |
| Apr 16, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contain Open, Classified |
IZL | K211423 |
| Apr 16, 2025 | Micro-X Ltd. Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contain Open, Classified |
IZL | K211423 |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35;
MICRO-X Rover Mobile X-ray System, # MXU-RV71 Open, Classified |
IZL | K211423 |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35 Open, Classified |
IZL | K211423 |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV19 Open, Classified |
IZL | K211423 |
| Nov 27, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35 Open, Classified |
IZL | K211423 |
| Sep 23, 2022 | Micro-X Ltd. MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Open, Classified |
IZL | K211423 |