FDA 510(k) Application Details - K221996

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K221996
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	P-Cure Ltd. 14 Carmel St. Shilat 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	07/06/2022
Decision Date	03/20/2023
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