FDA 510(k) Application Details - K121653

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K121653
Device Name	System, Therapeutic, X-Ray
Applicant	CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE DUBLIN, CA 95030 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	06/05/2012
Decision Date	12/27/2012
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