FDA 510(k) Application Details - K210632

Device Classification Name	More FDA Info for this Device
510(K) Number	K210632
Device Name	Contour ProtegeAI
Applicant	MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 US Other 510(k) Applications for this Company
Contact	Lynn Hanigan 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	03/03/2021
Decision Date	10/20/2021
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