FDA 510(k) Application Details - K101036

Device Classification Name	Collimator, Manual, Radiographic   More FDA Info for this Device
510(K) Number	K101036
Device Name	Collimator, Manual, Radiographic
Applicant	SHIMADZU CORP. 20101 SOUTH VERMONT AVE. TORRANCE, CA 90502-1328 US Other 510(k) Applications for this Company
Contact	DONALD KARLE Other 510(k) Applications for this Contact
Regulation Number	892.1610   More FDA Info for this Regulation Number
Classification Product Code	IZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2010
Decision Date	08/26/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review