FDA 510(k) Application Details - K022342

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K022342
Device Name	Camera, Scintillation (Gamma)
Applicant	ANZAI MEDICAL CO, LTD. 2305 GOLD MINE RD. BROOKEVILLE, MD 20833-2233 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY 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	07/18/2002
Decision Date	10/09/2002
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