FDA 510(k) Application Details - K010116

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K010116
Device Name	System, X-Ray, Mammographic
Applicant	PLANMED OY 1250 GREENBRIAR, SUITE A ADDISON, IL 60101 US Other 510(k) Applications for this Company
Contact	BOB PIENKOWSKI Other 510(k) Applications for this Contact
Regulation Number	892.1710   More FDA Info for this Regulation Number
Classification Product Code	IZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2001
Decision Date	03/15/2001
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