# K112969: Air-Bag System

- Pathway: 510(k) (Traditional)
- Applicant: Niigata Mechatronics Co., Ltd.
- Decided: Mar 14, 2012 after 161 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of this Air-Bag System is to monitor patient's respiratory cycle and to fix the trunk of the body of patient during radiation therapy. This Air-Bag System can properly press the abdomen and stabilize patient's positioning repeatability easily in continuous radiation therapy.

Source page: https://510kreport.com/device/K112969
Methodology: https://510kreport.com/methodology