FDA 510(k) Application Details - K131433

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K131433
Device Name	System, X-Ray, Tomography, Computed
Applicant	ISYS MEDIZINTECHNIK GMBH 56 WESTCOTT ROAD STAMFORD, CT 06902 US Other 510(k) Applications for this Company
Contact	CORNELIA DAMSKY Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2013
Decision Date	03/11/2014
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