Axxent Cervical Applicator
FDA 510(k)Class II (US FDA 510(k))
by Icad, Inc.
Identifiers
- 510(k) Number
- K141343 FDA 510(k)
- FDA Product Code
- JAD 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 AXXENT CERVICAL APPLICATOR is a reusable, non-sterile accessory for the Axxent Electronic Brachytherapy System. It utilizes a miniaturized X-ray source to deliver high-dose rate, low-energy radiation that mimics Iridium-192 penetration and dose characteristics.
It requires steam sterilization before use and an Applicator Clamp for stabilization during treatment. The device is used in clinical settings for intracavitary delivery of radiation in gynecological cancer care and is authorized under FDA 510(k) clearance K141343.
Frequently asked questions
What is the AXXENT CERVICAL APPLICATOR used for?
The AXXENT CERVICAL APPLICATOR is used for intracavitary delivery of radiation in gynecological cancer care as part of the Axxent Electronic Brachytherapy System, delivering high-dose rate, low-energy radiation that mimics Iridium-192 penetration and dose characteristics.
Is the AXXENT CERVICAL APPLICATOR sterile when supplied?
The AXXENT CERVICAL APPLICATOR is supplied as a non-sterile reusable accessory and requires steam sterilization before each clinical use to ensure it is safe for patient contact during intracavitary procedures.
What components are needed to use the AXXENT CERVICAL APPLICATOR during treatment?
The AXXENT CERVICAL APPLICATOR requires an Applicator Clamp for stabilization during treatment and must be used with the Axxent Electronic Brachytherapy System, which provides the miniaturized X-ray source for radiation delivery.
Can the AXXENT CERVICAL APPLICATOR be reused after sterilization?
Yes, the AXXENT CERVICAL APPLICATOR is designed as a reusable device and can be used multiple times after undergoing proper steam sterilization between uses, as specified in its labeling and intended for repeated clinical application.
What regulatory pathway authorized the AXXENT CERVICAL APPLICATOR?
The AXXENT CERVICAL APPLICATOR received authorization through the FDA 510(k) clearance process under submission K141343, which determined it to be substantially equivalent to a legally marketed predicate device.
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: AXXENT CERVICAL APPLICATOR (K141343) — FDA 510(k) | Innolitics, XOFT AXXENT CERVICAL APPLICATORS (K123442) - Innolitics, Icad Axxent Cervical Applicator - allmed.wiki, Cervical Applicator | Xoft | Elekta
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141343 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA 510(k) K141343 24 fields · synced Sep 24, 2026