FDA 510(k) Application Details - K123408

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K123408
Device Name	Camera, Scintillation (Gamma)
Applicant	DIGIRAD CORP. 13950 STOWE DRIVE POWAY, CA 92064-8803 US Other 510(k) Applications for this Company
Contact	MATTHEW OLOW Other 510(k) Applications for this Contact
Regulation Number	892.1100   More FDA Info for this Regulation Number
Classification Product Code	IYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2012
Decision Date	01/15/2013
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