FDA 510(k) Application Details - K130549

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K130549
Device Name	System, Therapeutic, X-Ray
Applicant	CARL ZEISS MEDITEC INC 5160 HACIENDA DR. DUBLIN, CA 94568 US Other 510(k) Applications for this Company
Contact	SARAH HARRINGTON Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2013
Decision Date	06/26/2013
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