Micro C Medical Imaging System, M01
OXOS Medical, Inc.The Micro C Medical Imaging System, M01 by OXOS Medical, Inc. is a handheld, portable mobile X-ray device intended for use by trained clinicians to capture diagnostic images of extremities. It features an AI-based software called AiLARA that recommends power settings and exposure times to optimize image quality and reduce retakes, enhancing clinician efficiency and patient safety.
Intended Use
The M01 System is a hand-held X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of extremities.
Technology
The device consists of three subsystems (Emitter with control panel and computer vision camera, Cassette with digital detector and status lights, and Control Unit with high voltage generator and computing power). It includes AI-based software (AiLARA) modes for automatic selection of power and exposure time without user input, using computer vision for emitter positioning relative to patient anatomy.
Performance
Performance testing included AI algorithm verification on training and testing datasets, software verification, image quality validation with phantom images reviewed by radiologists and surgeons, radiation dose testing for compliance with diagnostic reference levels, and usability evaluation with trained operators. All tests support device safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/23/2021
5 months - 2
FDA Approval
2/4/2022
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