FDA 510(k) Application Details - K020140

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K020140
Device Name System, Image Processing, Radiological
Applicant VOXAR LIMITED
BONNINGTON BOND, 2 ANDERSON PL
EDINBURGH EH6 5NP GB
Other 510(k) Applications for this Company
Contact CONRAD CMIN
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 01/16/2002
Decision Date 01/28/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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