# K131313: Active Breathing Coordinator

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Corp.
- Decided: Aug 7, 2013 after 92 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864886 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003330: Aktina Medical Physics Corporation Active Breathing Coordinator (Abc), Aktina Medical Physics Corp. (2001) Summary page 1.
- K031385: Anzai AZ-733 Respiratory Gating System, Anzai Medical Co., Ltd. (2003) Summary page 1.

## Most influential descendants
- K151097: Active Breathing Coordinator (2015), 0 descendants of its own

## Indications for use
The Active Breathing Coordinator is indicated for use when there is a need to reduce the anatomical movement in the thorax and abdomen caused by breathing and cardiac motion. It is intended for breath-hold (BH) during simulation and delivery of External Beam Radiation Therapy (EBRT) using photons, in single or multiple fractions, administered via static and/or dynamic delivery processes, in any and all areas of the body where such treatment is indicated. It also provides electrical prompts and status information for the Elekia Limited Response TM gating interface when automated gating of the linac is used. The Active Breathing Coordinator is specifically indicated for: a. Breast tumors, including total and partial breast irradiation techniques, whore immobilized anatomy provided by deep inspiration breath-hold (DISH) allows critical organ sparing, such as decreasing radiation dose to heart, lung and other surrounding normal tissue. b. Lung cancers and other thoracic tumors (such as esophagus, lymphoma, and metastatic lesions) where immobilized anatomy provided by DIBH allows critical organ spaning, including reducing both dose and volume of irradiated normal tissue, and enabling potential reduction of tumor target margins. Also included is the use of linac-based Stereotactie Radiosurgery (SRS) and Stereoitactic Radiation Therapy (SRT) that may be employed to treat such lesions. c. Liver tumors, where immobilized anatomy provides critical organ sparing, including reducing both dose and volume of irradiated normal tissue enabling potential reduction of tumor target tissue margins. Also included is the use of linac-based SRS and SRT that may be employed to treat such lesions. d. Pancreatic tumors, where immobilized anatomy allows critical organ sparing including reducing both dose and volume of irradiated normal tissue, enabling potential reduction of tumor target margins. Also included is the use of linac-based SRS and SRT that may be employed to treat such lesions.

Source page: https://510kreport.com/device/K131313
Methodology: https://510kreport.com/methodology