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Active Breathing Coordinator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K131313

by Aktina Medical Corp

Identifiers

510(k) Number
K131313 FDA 510(k)
FDA Product Code
IYE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Active Breathing Coordinator is a medical device classified as a Linear Accelerator, designed to coordinate and monitor patient breathing during radiation therapy. It integrates with linear accelerator systems to ensure precise alignment of treatment beams with patient respiration, enhancing accuracy in delivering radiation doses to targeted areas while minimizing exposure to surrounding tissues.

This device is intended for use in radiology settings and is supplied as a reusable component. It is not sterile and requires proper cleaning and maintenance between uses. The Active Breathing Coordinator is authorized under FDA 510K clearance and the Medical Device Directive (MDD), adhering to regulatory standards for Class II devices. It is supplied with specific mouthpiece support options and accessories, as detailed in manufacturer documentation.

Manufacturer's product page: Request an Aktina Medical Active Breathing Coordinator User Manual

Frequently asked questions

What is the primary purpose of the Active Breathing Coordinator in radiation therapy?

The Active Breathing Coordinator is designed to coordinate and monitor a patient’s breathing during radiation therapy. It integrates with linear accelerator systems to ensure precise alignment of treatment beams with the patient’s respiration, which helps improve the accuracy of radiation delivery to targeted areas while reducing exposure to surrounding healthy tissues.

Is the Active Breathing Coordinator intended for single-use or reusable applications?

The Active Breathing Coordinator is supplied as a reusable component. Since it is not sterile, it requires proper cleaning and maintenance between uses to ensure safety and functionality.

What regulatory approvals does the Active Breathing Coordinator hold, and how does this affect its use?

The device holds FDA 510K clearance and complies with the Medical Device Directive (MDD), classifying it as a Class II device. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets EU and U.S. safety and performance standards for use in radiology settings.

What types of accessories or support options are included with the Active Breathing Coordinator?

The Active Breathing Coordinator is supplied with specific mouthpiece support options and accessories, though the exact configurations are detailed in the manufacturer’s documentation. These accessories are intended to enhance compatibility with different patient needs during radiation therapy.

How does the Active Breathing Coordinator integrate with existing radiation therapy equipment?

The device is classified as a Linear Accelerator accessory and is explicitly designed to integrate with linear accelerator systems. Its purpose is to synchronize treatment beams with patient respiration, ensuring precise delivery of radiation doses while minimizing exposure to non-targeted areas.

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: Elekta and Aktina ABC Systems - Aktina Medical, Request an ABC User Manual - English - Aktina Medical, Aktina Medical Physics Corporation Active Breathing Coordinator (Abc ..., PDF I W2 3 - Food and Drug Administration

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aktina Medical Corp
FDA Applicant
Aktina Medical Corp.

Sources (2)

  • FDA 510(k) K131313 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026