FDA 510(k) Application Details - K172855

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K172855
Device Name System, Image Processing, Radiological
Applicant Vital Images, Inc.
5850 Opus Parkway
Suite 300
Minnetonka, MN 55343-4414 US
Other 510(k) Applications for this Company
Contact Katie Ryan
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 09/20/2017
Decision Date 10/05/2017
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