FDA 510(k) Application Details - K080890

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K080890
Device Name System, Image Processing, Radiological
Applicant CMT MEDICAL TECHNOLOGIES, LTD.
6 SIRENI
HAIFA 32972 IL
Other 510(k) Applications for this Company
Contact DAN LAOR
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 03/31/2008
Decision Date 04/29/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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