FDA 510(k) Application Details - K083645

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K083645
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	5 STAR MEDICAL, INC. 11515 PROSPEROUS DR. ODESSA, FL 33556 US Other 510(k) Applications for this Company
Contact	TERRY L ANCAR Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	MQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2008
Decision Date	02/24/2009
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