FDA 510(k) Application Details - K012165

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K012165
Device Name	System, X-Ray, Stationary
Applicant	NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	LISA DIMMICK Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2001
Decision Date	09/19/2001
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