# K031385: Anzai AZ-733 Respiratory Gating System

- Pathway: 510(k) (Traditional)
- Applicant: Anzai Medical Co., Ltd.
- Decided: Nov 10, 2003 after 193 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: 2 generations back to K864886 (1987). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983629: RPM Respiratory Gating System, Varian Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K160432: Anzai Respiratory Gating System (2016), 2 descendants of its own
- K170719: Anzai Respiratory Gating System (2017), 1 descendant of its own
- K131313: Active Breathing Coordinator (2013), 1 descendant of its own
- K243900: eMotus Respiratory Motion Management System (2025), 0 descendants of its own
- K151097: Active Breathing Coordinator (2015), 0 descendants of its own

## Indications for use
The AZ-733 Respiratory Gating System 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/K031385
Methodology: https://510kreport.com/methodology