FDA 510(k) Application Details - K201501

Device Classification Name	Lung Computed Tomography System, Computer-Aided Detection   More FDA Info for this Device
510(K) Number	K201501
Device Name	Lung Computed Tomography System, Computer-Aided Detection
Applicant	MeVis Medical Solutions AG Caroline-Herschel-Strasse 1 Bremen 28359 DE Other 510(k) Applications for this Company
Contact	Rolf Rzodeczko Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	OEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2020
Decision Date	02/23/2021
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