FDA 510(k) Application Details - K082368

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K082368
Device Name	System, Tomography, Computed, Emission
Applicant	DIGIRAD CORP. 13950 STOWE DRIVE POWAY, CA 92064-8803 US Other 510(k) Applications for this Company
Contact	Joel Tuckey 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	08/18/2008
Decision Date	09/12/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review