FDA 510(k) Application Details - K043441

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K043441
Device Name	System, Tomography, Computed, Emission
Applicant	SEGAMI CORPORATION 8325 GUILFORD RD., SUITE B COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	PHILIPPE BRIANDET Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2004
Decision Date	01/13/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review