FDA 510(k) Application Details - K172513

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K172513
Device Name System, Image Processing, Radiological
Applicant JointVue LLC
2099 Thunderhead Rd., Suite 104
Knoxville, TN 37922 US
Other 510(k) Applications for this Company
Contact Mohamed R. Mahfouz
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 08/21/2017
Decision Date 09/14/2017
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 Y
Expedited Review



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