FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

Spine CAMP™ (1.1) is an automated software that analyzes X-ray images of the lumbar and cervical spine to generate measurements and visualizations of spinal alignment, stability, degeneration, and motion. It supports healthcare professionals in clinical decisions related to spinal health by producing detailed reports from radiographic data.

FDA #
K231668
Product Code
QIH

Axial3D Insight is a cloud-based service that processes medical imaging DICOM data to create detailed 3D digital files or physical 3D printed models. These models assist clinicians in treatment planning and diagnosis across orthopedic trauma, maxillofacial, and cardiovascular applications, improving surgical preparation and outcomes.

FDA #
K222745
Product Code
QIH

Bladder AI is a software designed to assist healthcare providers in measuring bladder volume from ultrasound images using machine learning. It supports image-based assessment, landmark placement, and report generation for patients aged 2 years and older, improving workflow efficiency and accuracy in bladder volume quantification.

FDA #
K230497
Product Code
QIH

The Voluson SWIFT and Voluson SWIFT+ are advanced diagnostic ultrasound systems used by healthcare professionals for imaging and analyzing the human body and fluids. These systems support multiple clinical applications including fetal/obstetrics, abdominal, cardiac, musculo-skeletal, and vascular imaging using various ultrasound modes such as B-mode, Doppler, 3D/4D imaging, and elastography. They feature AI-assisted tools like Auto-Caliper for improved measurement accuracy, enhancing clinicians' ability to perform exams efficiently and precisely in hospital or clinical settings.

FDA #
K230346
Product Code
IYN

HepaFatSmart (V2.0.0) is an automated AI-assisted software that analyzes magnetic resonance imaging (MRI) datasets to measure liver fat quantitatively. It calculates volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grading without user input, supporting clinical diagnosis and management of fatty liver disease and screening of liver transplant donors. This software helps clinicians by providing consistent, reproducible liver fat measurements from MRI scans, aiding patient care in liver-related conditions.

FDA #
K231459
Product Code
LNH

DeepCatch is software that analyzes whole-body CT scans to automatically identify and measure various anatomical structures like skin, muscle, fat, internal organs, and the central nervous system. It produces 3D models and quantitative data to help doctors better understand the patient's body composition and anatomy, aiding clinical decisions by providing accurate volume and proportion measurements.

FDA #
K223556
Product Code
QIH

EyeArt v2.2.0 is an AI-based software device designed to automatically detect more than mild and vision-threatening diabetic retinopathy in retinal fundus images. It assists healthcare providers by analyzing images captured from specific retinal cameras and providing diagnostic screening results to help identify retinal disease in adults with diabetes, facilitating early detection and treatment.

FDA #
K223357
Product Code
PIB

IB Lab LAMA is a software tool that automatically analyzes full leg X-rays to measure discrepancies in limb length and assess knee alignment. It uses AI deep learning technology to provide precise geometric measurements to assist healthcare professionals in evaluating leg deformities and alignment issues, thereby supporting diagnosis and treatment planning.

FDA #
K223646
Product Code
QIH

CAC Software by Imbio, Inc. is a machine learning-based post-processing tool that analyzes non-contrast CT images of the chest to assess calcified plaques in the coronary arteries. It quantifies the calcification burden by producing scores and metrics that help clinicians evaluate coronary artery disease risk. The software outputs annotated images and a detailed report, integrating into the standard DICOM workflow to assist physicians without making standalone diagnoses.

FDA #
K230112
Product Code
JAK

FEops HEARTguide™ ALPACA is an AI-enabled medical imaging software system that helps clinicians visualize and measure detailed heart and vessel structures from CT images. It aids in planning minimally invasive heart procedures by providing automated segmentation, 3D visualization, measuring tools, and reporting. This software supports better procedural decisions by combining anatomical insights with clinical evaluation.

FDA #
K223855
Product Code
QIH
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