FDA 510(k) Application Details - K111299

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K111299
Device Name	System, Therapeutic, X-Ray
Applicant	XOFT, AN ICAD COMPANY 345 POTRERO AVENUE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	STEVE LIN Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2011
Decision Date	07/20/2011
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