Xoft Axxent Cervical Applicators
FDA 510(k)Class II (US FDA 510(k))
by Icad, Inc.
Identifiers
- 510(k) Number
- K123442 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xoft Axxent Cervical Applicators are remote-controlled radionuclide applicators designed for intracavitary radiation therapy. These devices are used to deliver targeted radiation to cancers of the uterus, cervix, endometrium, and vagina.
The system features three channels for a miniaturized X-ray source and utilizes titanium applicator walls to minimize scatter radiation. These applicators are available in a range of sizes and have received FDA 510(k) clearance.
Frequently asked questions
What are the Xoft Axxent Cervical Applicators used for?
These applicators are designed for intracavitary radiation therapy. They are used to deliver targeted radiation treatment for cancers located in the uterus, cervix, endometrium, and vagina.
How does the applicator system function during treatment?
The system features three distinct channels specifically designed to house a miniaturized X-ray source. The applicator walls are constructed from titanium, which is used to minimize scatter radiation during the delivery of the therapy.
Are there different sizes available for these applicators?
Yes, the Xoft Axxent Cervical Applicators are available in a range of sizes to accommodate different clinical needs and anatomical requirements during intracavitary radiation procedures.
What is the regulatory status of this device?
The Xoft Axxent Cervical Applicators have received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: Cervical Applicator | Xoft | Elekta, Axxent® Controller | Xoft | Elekta, Controller - iCAD - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123442 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA 510(k) K123442 24 fields · synced Sep 24, 2026