FDA 510(k) Application Details - K060505

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K060505
Device Name System, Image Processing, Radiological
Applicant BARCOVIEW MIS EDINBURGH
BONNINGTON BOND, 2 ANDERSON PL
EDINBURGH EH6 5NP GB
Other 510(k) Applications for this Company
Contact NEIL PHILLIPS
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 02/27/2006
Decision Date 03/29/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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