FDA Radiology AI Devices

The InsightersTM Single-use Bronchoscope System is a medical imaging device consisting of disposable flexible bronchoscopes and a compatible workstation display. It provides clear, real-time images for clinicians to observe, diagnose, and treat diseases affecting the trachea, bronchi, and lungs. The device enhances clinical workflow with its portability, image clarity, and single-use design to reduce risk of infection.

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.

Clever One is dental imaging software designed to acquire, process, view, and analyze 2D and 3D medical images from dental CT, panoramic, cephalometric, and intraoral imaging devices. It helps clinicians by providing advanced visualization and analytic tools such as bone density analysis, implant planning, and multi-planar reconstructions, facilitating more accurate diagnostics and treatment plans.

The RadiForce MX317W-PA is a color LCD monitor designed for displaying digital images of histopathology slides acquired from whole-slide imaging scanners. It aids pathologists in the review and interpretation of these slides for primary diagnosis by providing high-quality image visualization with calibrated display modes and color accuracy.

The HJY VisualNext 3D Endoscopic Vision System is a medical device designed to provide surgeons with a 3D visual of internal surgical sites during neurological, spinal, and general surgeries. It uses dual CMOS sensors and integrated LED lighting to capture and display high-resolution 3D images on an external monitor, helping clinicians better visualize the surgical area for improved precision and outcomes.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.

SMARTDent is a software solution developed by RAY Co., Ltd. that helps dental professionals manage and analyze various types of dental imaging, including CT, panoramic, cephalometric, and intraoral X-rays. It streamlines image management and provides tools that support diagnosis, thereby assisting clinicians in dental care.

The Diagnostic X-ray System is a mobile fluoroscopic X-ray system with a C-arm and digital imaging capabilities. It is used by trained medical professionals for real-time imaging guidance during diagnostic, interventional, and surgical procedures, helping clinicians visualize inside the body with X-rays from various angles.

Mixed Reality Spine Navigation is an accessory software used with Brainlab's Spine & Trauma Navigation platform. It employs a mixed reality headset (Magic Leap 2 Medtech) to provide surgeons with 2D and 3D floating visualizations of the patient's spine anatomy and tracked surgical instruments during pedicle screw placement surgery, enhancing intraoperative navigation and precision.

OTS Hip is an orthopedic surgical system designed to aid surgeons in preoperative planning and intraoperative navigation of hip replacement surgeries. It uses CT and X-ray medical imaging data and combines software and hardware components to create a 3D model of the patient's unique anatomy, guiding surgical instrument and prosthetic placement in real-time. This helps improve the accuracy and safety of total hip arthroplasty procedures.