FDA 510(k) Application Details - K061871

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K061871
Device Name	System, X-Ray, Angiographic
Applicant	LEICA MICROSYSTEMS, INC. 2337 LUCKY JOHN DRIVE PARK CITY, UT 84060 US Other 510(k) Applications for this Company
Contact	MAX STURGIS Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2006
Decision Date	09/20/2006
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