INTRABEAM (700) +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241174 FDA 510(k)
- FDA Product Code
- JAD FDA 510(k)
- Models / Variants
- INTRABEAM (700) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5900 FDA 510(k)
- Regulation Number
- 892.5900 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The INTRABEAM (700) is a mobile intraoperative radiotherapy system designed to deliver low-energy X-ray radiation during surgery. It is classified as a therapeutic X-ray device and is used for intracavity, interstitial, and contact radiotherapy to treat tumors or tumor beds. The system operates under the regulatory category of Radiology and is intended for intraoperative use to provide targeted radiation therapy directly at the surgical site.
The INTRABEAM (700) system includes accessories such as the INTRABEAM SMART Stand for positioning, the INTRABEAM SMART Spherical Applicator for cavity-based treatments, the INTRABEAM Spherical Sizer Set for applicator selection, and the INTRABEAM Needle Applicator for interstitial applications. These components are supplied as single-use items to eliminate post-operative sterilization requirements. The device is FDA-cleared under 510(k) K241174 and falls under Class II regulatory classification (FDA code JAD). It is intended for use in radiology settings and adheres to FDA regulation 892.5900.
Frequently asked questions
What is the INTRABEAM 700 system used for in surgery?
The INTRABEAM 700 is designed for intraoperative radiotherapy, delivering targeted low-energy X-ray radiation directly to tumor sites or tumor beds during surgery. It is specifically intended for intracavity (inside body cavities), interstitial (between tissues), and contact radiotherapy applications, ensuring precise treatment at the surgical site while minimizing exposure to surrounding healthy tissue.
Are the INTRABEAM accessories single-use or reusable?
All INTRABEAM accessories—including the SMART Stand, SMART Spherical Applicator, Spherical Sizer Set, and Needle Applicator—are supplied as single-use items. This design eliminates the need for post-operative sterilization, reducing infection risks and operational complexity while ensuring consistent performance for each procedure.
How does the INTRABEAM Spherical Sizer Set help in treatment planning?
The INTRABEAM Spherical Sizer Set is used to select the appropriate applicator size for cavity-based treatments. By providing a range of spherical applicators, it ensures the treatment area is accurately matched to the patient’s anatomy, optimizing radiation delivery and improving outcomes for intracavity procedures like those in gynecological or breast surgeries.
What regulatory approval does the INTRABEAM 700 hold, and where is it classified?
The INTRABEAM 700 system holds FDA 510(k) clearance under reference number K241174, classified as a Class II therapeutic X-ray device under the product code JAD. It adheres to FDA regulations (892.5900) and is intended for use in radiology settings, where it provides intraoperative radiation therapy with precise targeting during surgical procedures.
Why is the INTRABEAM system considered mobile for intraoperative use?
The INTRABEAM 700 is designed as a mobile system to facilitate intraoperative radiotherapy, allowing clinicians to deliver targeted radiation directly at the surgical site without requiring the patient to transfer to a separate radiation facility. This mobility enhances workflow efficiency, reduces patient discomfort, and ensures timely treatment during critical phases of surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZEISS INTRABEAM 700 | Intraoperative Radiotherapy System, INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM ..., INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241174 | Class II | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
- FDA Applicant
- Carl Zeiss Meditec, AG
Sources (1)
- FDA 510(k) K241174 24 fields · synced Oct 6, 2026