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.

The 16ch Flex SPEEDER Medium and Large 1.5T coils are receive-only, 16-channel phased array coils designed to be used with Canon 1.5T MRI systems. These coils help produce high-quality diagnostic images of general human anatomy, assisting clinicians in accurately interpreting MRI scans for patient diagnosis.

FDA #
K244054
Product Code
MOS

The InkSpace Imaging Small Body Array is a flexible, receive-only MRI coil designed for use with Siemens 1.5T MRI systems. It helps capture high-quality diagnostic images of various body parts such as the heart, spine, joints, and prostate, assisting physicians and radiologists in making accurate diagnoses. The coil's flexible design improves patient comfort and scanning convenience.

FDA #
K243675
Product Code
MOS
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