eMotus Respiratory Motion Management System

Q: What is the product code of K243900?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.

FDA 510(k) K243900 · Empnia, Inc.

Substantially Equivalent

510(k) numberK243900

Submission

Device name: eMotus Respiratory Motion Management System
Applicant: Empnia, Inc.
Edina, MN, US
Received: December 19, 2024
Decision date: June 27, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LHN – System, Radiation Therapy, Charged-Particle, Medical
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5050
Specialty: Radiology

Other 510(k)s with product code LHN

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K253406	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional	Mevion Medical Systems, Inc.	03/25/2026SE
K250986	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional	Mevion Medical Systems, Inc.	09/12/2025SE
K242418	P-Cure Proton Therapy System (PPTS)LHN · Traditional	P-Cure, Ltd.	05/12/2025SE
K232032	Probeat-FrLHN · Traditional	Hitachi, Ltd. Radiation Oncology Systems…	01/12/2024SE
K231863	ProBeam 360° Proton Therapy System v2.0 (Multiroom)LHN · Traditional	Varian Medical Systems, Inc.	10/06/2023SE
K221996	P-Cure Proton Beam Therapy SystemLHN · Traditional	P-Cure, Ltd.	03/20/2023SE
K220883	Small Field ApplicatorLHN · Traditional	Hitachi, Ltd. Radiation Oncology Systems…	12/15/2022SE
K221791	ProBeam 360° Proton Therapy SystemLHN · Traditional	Varian Medical Systems, Inc.	12/01/2022SE

Questions and answers

When was eMotus Respiratory Motion Management System cleared by the FDA?

eMotus Respiratory Motion Management System (K243900) received a 510(k) decision of Substantially Equivalent on June 27, 2025, 190 days after the submission was received.

What is the product code of K243900?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.