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.

ANKYRAS is a medical software device designed to assist clinicians in visualizing cerebral blood vessels and simulating the placement and sizing of neurointerventional braided endovascular devices such as flow diverters. It helps physicians plan neurovascular interventions by allowing 3D modeling based on imaging data from 3D rotational angiography, offering features like segmentation, centerline generation, and device simulation to improve pre-surgical planning and patient outcomes.

FDA #
K250160
Product Code
PZO

Sim&Size is a medical imaging software designed to help clinicians visualize cerebral blood vessels and simulate the placement and sizing of neurovascular implantable devices for preoperative planning. It uses 3D images from rotational angiography to provide 3D reconstructions, automatic vessel segmentation, and tools for sizing and positioning implantable devices, supporting better planning of neurovascular interventions and surgeries.

FDA #
K242124
Product Code
PZO
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