FDA 510(k) Application Details - K982862

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K982862
Device Name	System, Image Processing, Radiological
Applicant	APPLICARE MEDICAL IMAGING, B.V. 12300 TWINBROOK PKWY. SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/1998
Decision Date	10/21/1998
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