FDA Radiology AI Devices

The TMINI Miniature Robotic System is a robotic surgical tool designed to assist orthopedic surgeons in accurately placing knee implant components during total knee replacement surgery. It uses preoperative CT scans to generate 3D models for surgical planning and utilizes robotic guidance during surgery to ensure precise bone preparation and implant placement, improving surgical accuracy and patient outcomes.

The Navient Image Guided Navigation System (ENT) by ClaroNav is a surgical navigation tool designed to help ENT surgeons accurately locate anatomical structures by using preoperative CT and MR imaging combined with real-time optical tracking. It assists in planning and navigation during various ENT procedures, improving surgical precision and safety.

The CT Scanner TSX-501R/1 V11.1 by Canon Medical Systems Corporation is an advanced computed tomography system that uses a photon counting detector to capture high-quality cross-sectional volume images of the whole body. This system helps clinicians perform specialized studies by providing detailed imaging data to support diagnosis and treatment planning for adult patients.

PathPresenter Clinical Viewer is a web-based software tool designed to help pathologists view and manage high-resolution digital images of tissue slides. It facilitates diagnosis by allowing detailed image navigation, annotation, and measurement, improving pathology workflow and accuracy.

The FloPatch FP120 is a non-invasive cardiovascular blood flowmeter intended for use by medical professionals in hospitals and clinical settings. It utilizes continuous wave Doppler ultrasound to assess blood flow in peripheral vasculature. The device wirelessly transmits Doppler signals to a mobile application that displays blood flow measurements such as Max Velocity, Velocity Time Integral (VTI), and Corrected Flow Time, helping clinicians noninvasively monitor vascular health.

The 6600 Ultrasound System (MyLabA50 and MyLabA70) by Esaote is a multifunctional ultrasound scanner designed for use in various clinical applications such as cardiac, vascular, general imaging, and women's health. It uses advanced ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians collect, display, and analyze high-quality ultrasound images, supporting diagnosis and patient care. The system includes AI-powered features for automatic obstetric biometric measurements and automatic cardiac measurements, assisting clinicians by enhancing measurement accuracy and workflow efficiency.

CardIQ Suite is a non-invasive software that analyzes cardiac CT scans to visualize heart vessels, measure calcium deposits, and evaluate heart fat volume. It helps clinicians diagnose cardiovascular diseases, monitor disease progression, and plan treatment by providing detailed vessel measurements and calcium scoring from cardiac CT images.

The Happy Health Home Sleep Test is a software device that processes data collected from wearable sensors, such as a smart ring, to help healthcare providers evaluate adults suspected of sleep apnea. It records, analyzes, and presents biophysical signals like movement and blood flow to produce sleep parameters including apnea-hypopnea index and total sleep time, aiding clinicians in the diagnosis of sleep-related breathing disorders.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are sophisticated diagnostic ultrasound devices that integrate deep learning AI technology to assist clinicians in cardiac imaging. Their Smart View Select software automatically classifies and selects optimal ultrasound images for left ventricle analysis in echocardiography, enhancing workflow and diagnostic accuracy for cardiac assessment. These systems are used by trained healthcare professionals in clinics and hospitals for a broad range of diagnostic ultrasound applications.

The SKR 3000 is a digital radiography device by Konica Minolta designed to produce high-quality X-ray images of the human body for general-purpose diagnostic procedures. It replaces traditional film-based systems and includes features like advanced image processing and wireless connectivity. Its added indication includes pediatric imaging, helping clinicians accurately diagnose patients of all ages.