FDA 510(k) Application Details - K200323

Device Classification Name	More FDA Info for this Device
510(K) Number	K200323
Device Name	AutoContour
Applicant	Radformation, Inc. 335 Madison Avenue, 16th 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	02/10/2020
Decision Date	10/30/2020
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