FDA 510(k) Application Details - K181560

Device Classification Name	More FDA Info for this Device
510(K) Number	K181560
Device Name	Cios Alpha
Applicant	Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Patricia D. Jones Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2018
Decision Date	10/24/2018
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