FDA 510(k) Application Details - K010792

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K010792
Device Name	System, X-Ray, Mammographic
Applicant	DIGITEC MEDICAL SERVICE CORP. 465 MALTBIE ST. SUITE 407 LAWRENCEVILLE, GA 30045 US Other 510(k) Applications for this Company
Contact	JAMES J MCGINTY 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	03/16/2001
Decision Date	04/03/2001
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