12 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 29, 2026
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
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 self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 30, 2025
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 4, 2024
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·January 31, 2024
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·May 24, 2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·May 24, 2023
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-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025
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-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025