# K160432: Anzai Respiratory Gating System

- Pathway: 510(k) (Traditional)
- Applicant: Anzai Medical Co., Ltd.
- Decided: Apr 22, 2016 after 66 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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). 3 ancestors in all.
2 later devices descend 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)
- K031385: Anzai AZ-733 Respiratory Gating System, Anzai Medical Co., Ltd. (2003) Summary page 5.

## Most influential descendants
- K170719: Anzai Respiratory Gating System (2017), 1 descendant of its own
- K243900: eMotus Respiratory Motion Management System (2025), 0 descendants of its own

## Indications for use
The Respiratory Gating System AZ-733VI is intended to be used with diagnostic x-ray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.

Source page: https://510kreport.com/device/K160432
Methodology: https://510kreport.com/methodology