INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
Carl Zeiss Meditec AGThe 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.
Intended Use
The INTRABEAM is intended for use in radiotherapy treatments including intraoperative radiation to tumor margins or beds during intracavity and intraoperative radiotherapy treatments. The Needle Applicator is intended for intracranial tumor irradiation.
Technology
The INTRABEAM 700 system features a mobile cart with control console, software, an X-ray source (XRS 4) emitting low-energy (max 50keV) X-rays, and applicators designed to deliver targeted intraoperative radiation. The system includes software version 5.0, quality assurance tools, and connectivity options such as PACS and cloud platforms. The SMART Stand allows precise positioning with additional functions like RFID tagging and vibration damping.
Performance
Performance testing included non-clinical bench tests, software verification and validation, electromagnetic and radiation safety compliance with IEC standards, system level verification, and usability/human factors assessment. All tests demonstrated that the device meets its safety and performance requirements and is substantially equivalent to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/26/2024
8 months - 2
FDA Approval
1/10/2025
Other devices from Carl Zeiss Meditec AG
- CLARUS (700)2025 • 510K
- CLARUS2019 • 510K
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