K243900
- 510(k) number
- K243900
- Device name
- eMotus Respiratory Motion Management System
- Applicant
- Empnia, Inc. MN · US
- Product code
- LHN — System, Radiation Therapy, Charged-Particle, Medical
- Decision date
- 2025-06-27
- Date received
- 2024-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243900.pdf
Official FDA record: K243900
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.