FDA 510(k) Application Details - K243900

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K243900
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	EmpNia Inc. 4500 Lakeview Drive Edina, MN 55424 US Other 510(k) Applications for this Company
Contact	Manojeet Bhattacharya Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	LHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2024
Decision Date	06/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review