FDA 510(k) Application Details - K203258

Device Classification Name	Lung Computed Tomography System, Computer-Aided Detection   More FDA Info for this Device
510(K) Number	K203258
Device Name	Lung Computed Tomography System, Computer-Aided Detection
Applicant	Siemens Healthcare GmbH Siemensstr. 1 Forchheim 91301 DE Other 510(k) Applications for this Company
Contact	Abhineet Johri 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	11/05/2020
Decision Date	03/31/2021
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