FDA 510(k) Application Details - K242418

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K242418
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	P-Cure, Ltd. 14 Carmel St. Shilat Industrial Zone 7318800 IL Other 510(k) Applications for this Company
Contact	Ori Lubin 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	08/15/2024
Decision Date	05/12/2025
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