FDA 510(k) Application Details - K100001

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K100001
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	ALMANA MEDICAL IMAGING 8726 FERRARA CT NAPLES, FL 34114 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM, P.E. 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	01/04/2010
Decision Date	06/25/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review