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510(k) Data Aggregation
K Number
K201488Device Name
Rover
Manufacturer
Micro-X Ltd.
Date Cleared
2020-07-17
(43 days)
Product Code
IZL, LLZ, MQB
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Micro-X Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients treatment areas.
Device Description
The Rover product concept was developed under a contract from the Australian Department of Defense to fulfil a need for a full performance digital medical x-ray imager, light enough to be used in deployed medical facilities. Key Design Features:
- Full trauma imaging capability 40-110kV, 0.2-20mAs;
- Ultra-light weight at 105 kg;
- Ground Clearance allows for 75mm step up;
- Operation on uneven ground;
- Spare battery tray swap out in under a minute;
The unit uses FDA cleared digital image capture panels and software made by FujiFilm.
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