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.

DS Core Diagnosis by Dentsply Sirona Inc. is an AI-powered software designed to process radiological images automatically. It helps clinicians by analyzing medical images, enabling more efficient and accurate diagnosis in radiology.

FDA #
K250755
Product Code
QIH

The UNiD™ Spine Analyzer by Medicrea International is a software tool designed to automatically process radiological images of the spine. It helps clinicians by providing detailed analysis of spinal images, which facilitates diagnosis and treatment planning for spinal conditions.

FDA #
K251629
Product Code
QIH

Navigo Workstation 2.3 is a medical image processing system designed for radiology. It helps clinicians analyze radiological images by providing advanced image processing tools to assist in diagnosis and medical decision-making.

FDA #
K250664
Product Code
LLZ

RiasDR is a software product designed to acquire and process digital radiographic images, helping clinicians by efficiently managing and enhancing X-ray images for diagnosis and treatment planning.

FDA #
K251038
Product Code
LLZ

The InVision™ 3T Recharge Operating Suite is a system designed for magnetic resonance imaging (MRI). It helps clinicians by providing high-quality images of the body’s internal structures, aiding in diagnosis and treatment planning. This advanced MRI system supports detailed and clear imaging, improving patient care in radiology.

FDA #
K252239
Product Code
LNH

iPETcertum (v1.0) by Claritas HealthTech Pte Ltd is a radiological image processing system designed to assist clinicians by analyzing medical images to support patient diagnosis and management.

FDA #
K244016
Product Code
LLZ

The uMR Jupiter is an MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It produces detailed images of the body's internal structures using nuclear magnetic resonance, aiding clinicians in diagnosis and treatment planning.

FDA #
K250246
Product Code
LNH

The INNOVISION-DXII is a stationary X-Ray system used in radiology to capture high-quality X-ray images. It helps clinicians by providing reliable imaging for diagnosing various conditions, facilitating accurate patient assessment and treatment planning.

FDA #
K250790
Product Code
KPR

The Deepsight NeedleVue LC1 Ultrasound System is an imaging device that uses pulsed echo ultrasound technology. It helps clinicians visualize internal anatomy in real-time to guide procedures such as needle placements more accurately and safely.

FDA #
K250381
Product Code
IYO

The Revolution Vibe is a computed tomography (CT) imaging system developed by GE Medical Systems. It captures detailed cross-sectional X-ray images of the body, aiding clinicians in diagnosing and monitoring various conditions with high clarity and speed.

FDA #
K250941
Product Code
JAK
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