Cleared Traditional

eMotus Respiratory Motion Management System

K243900 · Empnia, Inc. · Radiology

Jun 2025

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K243900 is an FDA 510(k) clearance for the eMotus Respiratory Motion Management System, a System, Radiation Therapy, Charged-particle, Medical (Class II — Special Controls, product code LHN), submitted by Empnia, Inc. (Edina, US). The FDA issued a Cleared decision on June 27, 2025, 190 days after receiving the submission on December 19, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K243900 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2024
Decision Date	June 27, 2025
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF