FDA 510(k) Application Details - K230685

Device Classification Name	More FDA Info for this Device
510(K) Number	K230685
Device Name	AutoContour Model RADAC V3
Applicant	Radformation, Inc. 335 Madison Avenue, 4th floor New York, NY 10017 US Other 510(k) Applications for this Company
Contact	Kurt Sysock Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2023
Decision Date	04/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review