FDA 510(k) Application Details - K250035

Device Classification Name	More FDA Info for this Device
510(K) Number	K250035
Device Name	Contour ProtΘgΘAI+
Applicant	MIM Software Inc. 25800 Science Park Drive Suite 180 Cleveland, OH 44122 US Other 510(k) Applications for this Company
Contact	Sydney Lindner 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	01/07/2025
Decision Date	02/03/2025
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