FDA 510(k) Application Details - K193252

Device Classification Name	More FDA Info for this Device
510(K) Number	K193252
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	11/25/2019
Decision Date	07/02/2020
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