FDA Radiology AI Devices

ZeTTA PACS is a software system designed for hospitals and diagnostic centers to receive, store, retrieve, and display medical images from various modalities such as CT, MRI, ultrasound, and X-ray. It helps healthcare professionals securely access and analyze diagnostic images over hospital networks, supporting efficient image interpretation and management but does not provide diagnostic decision-making functions.

The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn sensor device designed to continuously measure oxygen saturation (SpO2) and pulse rate in infants. It sends the measured data via Bluetooth to a mobile device running a dedicated app for display and monitoring. This helps caregivers monitor infant vital signs in hospitals, home care, and medical facilities non-invasively in real time, with visual and auditory alarms for abnormalities.

MyShoulder Planner is a software tool designed for surgeons to plan total shoulder replacement surgeries. It processes CT scans to create 3D models of the patient's shoulder anatomy using machine learning algorithms, helping surgeons decide implant size and positioning before surgery. It also generates patient-specific reports and allows ordering of patient-matched guides to assist in surgery.

The Co-Ablation System with Sterile Co-Ablation Probe is a medical device that freezes and destroys solid tumors and abnormal tissue in various surgical fields using extreme cold temperatures. It is used in open, minimally invasive, or endoscopic procedures to treat cancers, benign tumors, skin lesions, and for pain management by freezing nerve tissue. The system works by delivering liquid nitrogen through a probe to freeze the target tissue under imaging guidance, allowing doctors to visualize the ice ball formation and control the treatment precisely for safer and more effective ablation.

The Alignment System Cranial by Brainlab AG is an image guided surgical system designed to assist neurosurgeons in planning and precisely guiding surgical instruments during cranial stereotactic procedures such as biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and laser interstitial thermal therapy (LITT). It uses optical tracking technology and specialized software to continuously track instrument positions relative to patient anatomy on pre- or intraoperative images, helping clinicians achieve accurate trajectories to improve procedural safety and effectiveness.

Bunkerhill AVC is a medical software designed to automatically detect and quantify calcium deposits on the aortic valve using non-contrast chest CT scans. It helps physicians by providing a region of interest and an estimated calcium score to assist during case review, improving the identification and assessment of aortic valve calcification in adult patients.

The DigitMI 930 is a PET/CT imaging system that combines positron emission tomography and computed tomography to produce detailed images of metabolic and physiological functions in the body. It helps clinicians detect, localize, evaluate, diagnose, and monitor a wide range of conditions including cancer, cardiovascular disease, and neurological disorders by providing precise anatomical and functional imaging.

Galen™ Second Read™ is a software tool that analyzes digital images of prostate biopsy slides to identify regions suspicious for prostate cancer. It flags slides initially diagnosed as benign if it detects potential cancer areas, providing pathologists with case-level alerts and heatmaps to assist in further review. This helps improve cancer detection beyond the initial pathology review but is not intended to replace standard pathology diagnosis.

MAGENTIQ-COLO (ME-APDS) is a computer-aided detection system used alongside standard white-light colonoscopy videos to help endoscopists identify suspicious regions indicative of polyps. It processes live video frames using AI to highlight possible lesions during colonoscopy, aiming to improve detection rates and assist clinicians in real-time without replacing clinical judgement or histopathological diagnosis.

The ClearPoint System (Software Version 3.0) is a software platform that assists neurosurgeons by providing precise stereotactic guidance during neurological procedures such as biopsies and deep brain stimulation lead placements. It integrates with MR and CT imaging to automatically identify and segment brain structures and hardware components, improving procedure planning and monitoring. This system enhances the clinician's ability to accurately navigate and operate within the brain, supporting safer and more effective interventions.