FDA 510(k) Application Details - K010275

Device Classification Name	Camera, Multi Format, Radiological   More FDA Info for this Device
510(K) Number	K010275
Device Name	Camera, Multi Format, Radiological
Applicant	AGFA MEDICAL IMAGING 12300 TWINBROOK PKWY, STE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	KIRSTEN PAULSON Other 510(k) Applications for this Contact
Regulation Number	892.2040   More FDA Info for this Regulation Number
Classification Product Code	LMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2001
Decision Date	04/27/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review