FDA 510(k) Application Details - K013620

Device Classification Name	System, X-Ray, Tomographic   More FDA Info for this Device
510(K) Number	K013620
Device Name	System, X-Ray, Tomographic
Applicant	MEDSTONE INTL., INC. 100 COLUMBIA, SUITE 100 ALISO VIEJO, CA 92656-4114 US Other 510(k) Applications for this Company
Contact	RON BERGESON Other 510(k) Applications for this Contact
Regulation Number	892.1740   More FDA Info for this Regulation Number
Classification Product Code	IZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2001
Decision Date	01/22/2002
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