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 INTRABEAM (700) system by Carl Zeiss Meditec AG is a mobile radiation therapy device designed to deliver targeted low-energy X-ray radiation during intraoperative, intracavity, interstitial, and contact radiotherapy treatments of tumors or tumor beds. It includes accessories such as a SMART Stand, spherical applicators for precise radiation delivery, and a sizer set to assist in applicator selection. The system aids clinicians by providing controlled radiation doses directly at the tumor site during surgery, potentially improving cancer treatment efficacy while sparing surrounding healthy tissue.

FDA #
K241174
Product Code
JAD
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