FDA 510(k) Application Details - K002590

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K002590
Device Name System, Image Processing, Radiological
Applicant CEDARA SOFTWARE CORP.
6509 AIRPORT RD.
MISSISSAUGA, ONTARIO L4V 1S7 CA
Other 510(k) Applications for this Company
Contact CAROL NAKAGAWA
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 08/21/2000
Decision Date 10/31/2000
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