FDA Radiology AI Devices
Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
Opcom Medical Inc.The Flexible Ureteroscope (U-Scope) by Opcom Medical Inc. is a sterile, single-use, flexible digital video ureteroscope designed to visualize the urinary tract (including urethra, bladder, ureter, and kidney calyces) using a miniature CMOS camera and LED illumination. It connects to a reusable camera-controlled unit which processes and displays images and videos, enabling physicians to perform diagnostic and therapeutic procedures. This system aids clinicians by providing live, high-quality imaging to guide interventions in the urinary tract.
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