FDA Expands Clearance of Portable X-Ray System for Pediatric Imaging
Emphasizing patient comfort and features to minimize radiation exposure, the MC2 portable X-ray device is now cleared for imaging of pediatric patients.
The Food and Drug Administration (FDA) has granted an expanded 510(k) clearance for imaging of pediatric patients to the MC2 portable X-ray platform.
OXOS Medical, the manufacturer of the device, said the
• The lightweight, wireless MC2 X-ray facilitates quick simple scans without the anxiety or fear that children may have with larger devices.
• Providing hands-free operation with a wireless foot pedal and the capability of handheld or mounted attachment to a clinical cart, the MC2 X-ray system emphasizes ergonomic ease of use for clinicians, according to OXOS Medical.
• Limiting the X-ray beam to the area of interest, the MC2 X-ray has an automatic collimator and OXOS Medical added that the device enables clinicians to fine-tune precision via manual collimation pucks and a pediatric filter.
"For decades, we’ve asked children to adapt to the machine, to hold still in scary rooms away from their parents. That’s backwards," said Evan Ruff, the CEO of OXOS Medical. "Technology should adapt to the child. MC2 proves that you don't need an off-base, lead-lined bunker to get a clear, safe diagnosis."
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