FDA Radiology AI Devices

aPROMISE X is a software platform for healthcare professionals and researchers that assists in accepting, transferring, storing, manipulating, quantifying, and reporting digital medical images from PSMA PET/CT scans. It allows users to visualize multiple scans, mark regions of interest, and perform quantitative analysis to help identify suspicious lesions in oncology cases, improving clinical efficiency and consistency.

Oxehealth Vital Signs is a software medical device that uses video footage from fixed-installation cameras to noninvasively measure pulse rate and estimated breathing rate through analysis of chest wall movements. It is designed for use in single occupancy rooms within hospitals and secured environments where healthcare professionals periodically monitor patients. This technology enables spot checks of vital signs without physical contact, supporting clinical monitoring while minimizing patient disturbance and infection risk.

The MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A are advanced MRI diagnostic systems that produce detailed cross-sectional images and spectra of the head, body, or extremities. The device uses sophisticated MRI pulse sequences and integrates deep learning-based reconstruction algorithms to produce high-quality images quickly and reliably, aiding physicians in diagnosis and in planning interventional procedures.

The EFAI RTSuite CT HN-Segmentation System is AI-powered software designed to assist radiation oncology professionals by automatically contouring organs at risk in head and neck CT images. It helps streamline radiation therapy treatment planning by providing initial segmentations that clinicians review and edit, improving workflow efficiency and accuracy.

The Philips Incisive CT is an advanced whole-body computed tomography system used to acquire detailed images of the head, body, heart, and vascular structures. It helps clinicians diagnose various conditions and supports low-dose lung cancer screening, improving patient care by providing high-quality diagnostic images efficiently.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to help hospital specialists prioritize and triage cases showing possible incidental Pulmonary Embolism. It provides notifications with compressed preview images for early attention but does not replace standard diagnostic review, working alongside existing workflows to speed up urgent case identification.

HealthOST is an AI-powered image processing software that analyzes CT scans of the spine to help clinicians detect and assess musculoskeletal diseases in patients aged 50 and older. It labels vertebrae, measures vertebral height loss, and calculates bone density using Hounsfield Units, providing quantitative data to aid diagnosis and treatment planning without replacing clinical judgment.

Videa Caries Assist is a cloud-based AI software that helps dentists detect dental caries by analyzing bitewing X-ray images. It automatically highlights areas with possible carious lesions, aiding dentists in diagnosis and improving accuracy, thereby supporting better patient care.

AI-Rad Companion Brain MR is software that assists clinicians by automatically analyzing brain MRI scans. It segments various brain structures, quantifies their volumes, and highlights white matter hyperintensities, comparing results to normal data. This helps radiologists make more accurate and efficient evaluations of brain health.

RayStation 11B is a radiation therapy treatment planning software that helps clinicians create, analyze, and manage radiation treatment plans for cancer patients. The software integrates imaging data, including CT and CBCT, to compute radiation doses accurately and supports the administration of treatments, improving clinical workflow and patient care.