FDA 510(k) Application Details - K202284

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K202284
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	Oncospace, Inc. 1812 Ashland Ave., Suite 100k Baltimore, MD 21205 US Other 510(k) Applications for this Company
Contact	Praveen Sinha Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	MUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2020
Decision Date	03/12/2021
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