FDA Radiology AI Devices

The i-STAT CG4+ cartridge with the i-STAT 1 System by Abbott Point of Care Inc. is a portable blood analyzer used for quantifying blood gases (pH, PO2, PCO2) and lactate levels in arterial, venous, and capillary whole blood. It provides quick and accurate testing at the point of care or in clinical laboratory settings, helping clinicians diagnose and manage respiratory, metabolic, and acid-base disorders as well as tissue hypoxia and lactic acidosis.

LUMYS (V1) is a medical software platform designed to assist clinicians in pre-surgical planning by providing 3D visualization and interactive image segmentation of CT scan data. Using Microsoft HoloLens 2 for a mixed reality view, it enables surgeons and remote collaborators to annotate and interact with medical images in real time during procedures, improving communication and surgical precision, but it is not intended for primary diagnosis.

Vscan Air is a pocket-sized, battery-operated ultrasound imaging system designed for use by trained healthcare professionals. It operates wirelessly with a mobile app and provides ultrasound images and measurements across many clinical areas including abdominal, cardiac, obstetrics, musculoskeletal, and vascular applications. The device incorporates AI features to enhance diagnostic accuracy and assist clinicians, such as automatic bladder volume measurement using deep learning, and real-time guidance for cardiac imaging.

The LumiRex Bronchoscope is a single-use flexible endoscope designed to provide real-time video imaging of the airways and tracheobronchial tree. It aids clinicians during endoscopic procedures by allowing visualization through a thin tube equipped with a camera and light source. The device can operate in wired or wireless modes, enabling easier maneuverability, and is designed for use in hospitals.

Persona C HR is a mobile C-arm X-ray device used to provide real-time fluoroscopic imaging guidance during various diagnostic, interventional, and surgical procedures. It helps clinicians visualize patient anatomy with high-quality images to assist in precise and effective treatment, excluding pediatric patients.

The Resolve Fundus Camera by Optain Health, Inc. is an automatic eye-fundus camera designed to take high-quality digital images of the retina with or without pupil dilation. It uses infrared tracking and autofocus to capture clear images that aid clinicians in evaluating ocular health. The device enhances diagnosis and monitoring of eye conditions by providing precise, easily accessible retinal images.

The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is software designed to help physicians analyze and observe images from ultrasound examinations. It supports data from specific diagnostic ultrasound systems and includes AI-enabled features for advanced cardiac motion tracking and measurement, aiding clinical decision-making in hospital and clinical settings.

The Flash Ultrasound System 5100 Point of Care by Philips Ultrasound LLC is a diagnostic ultrasound system designed for point-of-care use. It offers multimodal ultrasound imaging including B-mode, Doppler, and M-mode for a wide range of anatomical regions and clinical settings, enabling clinicians to perform fluid flow analysis and image diagnostics efficiently in environments like hospitals, emergency rooms, and outpatient clinics. This system helps healthcare professionals make faster and well-informed clinical decisions using advanced ultrasound technology in a compact and user-friendly device.

The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.

The Intracavitary/Interstitial System by Varian Medical Systems is a medical device used in cancer treatment for the uterus, cervix, and vagina. It employs HDR or PDR brachytherapy, guiding radioactive sources via hollow catheters and needles for precise radiation delivery, helping clinicians target tumors effectively while minimizing exposure to surrounding tissues.