510(k) K211423 ยท IZL System, X-Ray, Mobile
Rover
| Applicant | Micro-X Limited, Cloverly Park, AU |
| Decision | Substantially Equivalent, May 21, 2021 |
| Received | May 7, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211423
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV19 Open, Classified |
IZL | None listed |
| Dec 12, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35 Open, Classified |
IZL | None listed |
| 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 | None listed |
| Nov 27, 2024 | Micro-X Ltd. MICRO-X Rover Mobile X-ray System, # MXU-RV35 Open, Classified |
IZL | None listed |
| Sep 23, 2022 | Micro-X Ltd. MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.