FDA 510(k) Application Details - K242729

Device Classification Name	More FDA Info for this Device
510(K) Number	K242729
Device Name	AutoContour (Model RADAC V4)
Applicant	Radformation, Inc. 261 Madison Avenue 9th Floor New York, NY 10016 US Other 510(k) Applications for this Company
Contact	Jennifer Wampler 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	09/10/2024
Decision Date	12/09/2024
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