FDA 510(k) Application Details - K013291

Device Classification Name	System, Imaging, Holography, Acoustic   More FDA Info for this Device
510(K) Number	K013291
Device Name	System, Imaging, Holography, Acoustic
Applicant	ADVANCED DIAGNOSTICS, INC. 8112 304TH AVE. SE. PRESTON, WA 98050 US Other 510(k) Applications for this Company
Contact	STEVE HESLER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NCS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2001
Decision Date	11/14/2001
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