FDA 510(k) Application Details - K070205

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K070205
Device Name System, Image Processing, Radiological
Applicant ZIOSOFT, INC.
5405 ALTON PARKWAY
SUITE A530
IRVINE, CA 92604 US
Other 510(k) Applications for this Company
Contact MARC GOODMAN
Other 510(k) Applications for this Contact
Regulation Number 892.2050

  More FDA Info for this Regulation Number
Classification Product Code LLZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/22/2007
Decision Date 03/23/2007
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact