MC2 Portable X-ray System
Oxos MedicalThe MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.
Intended Use
The MC2 Portable X-ray System is designed to aid clinicians with point-of-care visualization and guidance during X-rays of distal extremities. It is intended for use in clinical environments and is not intended for surgical applications.
Technology
The MC2 device consists of a handheld emitter and cassette, powered by batteries and charged via wired charger. It uses an infrared tracking system for emitter positioning and a LIDAR system for ensuring safety by maintaining safe source-to-skin distance. It includes multiple safety interlocks to prevent unsafe imaging configurations. The device supports wireless connectivity to tablets or monitors via the OXOS Device App for image management and processing, including DICOM 3.14 greyscale calibration and image adjustment features. The device can perform single, serial, and fluoroscopy imaging modes with adjustable kV and mAs settings.
Performance
Performance testing included bench and software verification and validation, safety interlocks testing, and task-based image quality studies with radiologic technologists acquiring images across modes and expert radiologists rating image quality. Testing demonstrated the device meets design requirements, is safe and effective for its intended use, and the imaging performance is clinically adequate for orthopedic extremity imaging.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2024
6 months - 2
FDA Approval
12/6/2024
Other devices from Oxos Medical
- Micro C Medical Imaging System, M012022 • 510K
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