FDA 510(k) Application Details - K111758

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K111758
Device Name System, Image Processing, Radiological
Applicant DOG MICROSYSTEMS, INC.
116 PRINCIPALE
SUITE 200
GRANBY, QUEBEC J2G 2V2 CA
Other 510(k) Applications for this Company
Contact FLORENT CHANDELIER
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 06/22/2011
Decision Date 02/14/2012
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