MasteRad MiniX Mobile Digital Imaging System (Mini-X)
Medicatech USA Inc.The MasteRad MiniX Mobile Digital Imaging System (Mini-X) is a portable fluoroscopic X-ray system designed for real-time imaging and guidance during diagnostic radiography and surgical procedures of the extremities. Its mobility and advanced imaging technology facilitate easy positioning and high-quality visualization to assist medical professionals in various clinical settings, except neonates and mammography.
Intended Use
Mini-X is intended for use by trained medical professionals for fluoroscopic imaging and guidance during diagnostic radiography and surgical procedures of the extremities, excluding neonates and mammography.
Technology
The system is a portable mobile imaging system that acquires, processes, and displays fluoroscopic images using a low-powered mono-block generator and a dynamic flat-panel detector. The device operates from a standard 120VAC outlet and incorporates sophisticated software for image processing and display, with capabilities up to 30 frames per second.
Performance
Bench testing including phantom image analysis confirmed that the Mini-X performs equivalently to predicate devices in image quality, spatial resolution, and radiation safety. The device passed electrical, mechanical, and radiation safety tests and complies with relevant IEC and FDA standards. Software validation followed FDA guidance and cybersecurity considerations were addressed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/10/2024
8 months - 2
FDA Approval
5/16/2025
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