# K243900: eMotus Respiratory Motion Management System

- Pathway: 510(k) (Traditional)
- Applicant: Empnia, Inc.
- Decided: Jun 27, 2025 after 190 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: 5 generations back to K864886 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170719: Anzai Respiratory Gating System, Anzai Medical Co., Ltd. (2017) Summary page 5.

## Indications for use
The EmpNia eMotus system is used to measure and record the patient's respiratory waveform to aid with respiratory-synchronized image acquisition or reconstruction during CT diagnostic imaging or radiation treatment planning procedures, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with organ position verification for radiation therapy treatment using CT or Xray imaging by monitoring the patient's respiratory waveform during the image acquisition, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with radiation therapy treatment, where there is a risk of respiratory motion compromising the resulting treatment accuracy.

Source page: https://510kreport.com/device/K243900
Methodology: https://510kreport.com/methodology