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.
Tip: combine filters with the search box to narrow down devices.

Showing 1526 FDA devices matching your filters.

The Alphenix INFX-8000V is an interventional fluoroscopic X-ray system designed by Canon Medical Systems Corporation. It provides real-time X-ray imaging to assist clinicians during interventional procedures, allowing enhanced visualization of anatomy and devices, thereby improving procedure accuracy and patient care.

FDA #
K251602
Product Code
OWB

The Lux HD 2530 detector is a digital flat panel X-ray imager used in radiology to capture high-quality X-ray images. It helps clinicians obtain detailed radiographic images for diagnosis and treatment planning with improved image quality over traditional detectors.

FDA #
K252911
Product Code
MQB

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that help clinicians visualize and assess various body regions using pulsed Doppler technology. These systems support medical diagnosis by providing high-quality ultrasound images and measurements, facilitating patient care in many clinical settings.

FDA #
K251651
Product Code
IYN

The GT300 and GT300-C are dental computed tomography (CT) devices used in radiology to produce detailed X-ray images of the teeth and jaw. These devices assist clinicians in diagnosing and planning treatment by providing high-resolution images of dental structures.

FDA #
K250060
Product Code
OAS

ProKnow DS is an image processing system designed to assist clinicians by managing, analyzing, and improving the workflow of radiological image data. It helps healthcare professionals efficiently handle medical images to enhance patient care.

FDA #
K251363
Product Code
LLZ

AIAS Cephalon by metamorphosis GmbH is an AI software tool designed to assist in processing radiological images automatically, helping clinicians analyze medical images more efficiently and accurately.

FDA #
K252214
Product Code
QIH

deepLive (OSP12 + DMS) by DAMAE Medical is an imaging system that uses Optical Coherence Tomography to capture detailed internal images of tissues. This helps clinicians visualize microstructures that are important for diagnosis and treatment, potentially improving patient care through more precise imaging.

The Bunkerhill MAC is a computed tomography system that uses X-rays to produce detailed images of the body's internal structures. This device assists clinicians by providing high-resolution tomographic images to aid in diagnosis and treatment planning.

FDA #
K250662
Product Code
JAK

The EVIS EUS Ultrasound Gastrointestinal Videoscope by Olympus is an advanced endoscopic ultrasound device that allows physicians to visualize the gastrointestinal tract using ultrasound technology. This helps clinicians diagnose and assess gastrointestinal conditions more accurately by combining endoscopy with ultrasound imaging.

HPACS is an image processing system designed for radiology that helps clinicians by enhancing and managing medical images, potentially improving diagnosis and workflow efficiency.

FDA #
K250039
Product Code
LLZ
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