FDA 510(k) Application Details - K151988

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K151988
Device Name System, Image Processing, Radiological
Applicant VISIBLE PATIENT, SAS
1 PLACE DE L'HOPITAL
STRASBOURG 67091 FR
Other 510(k) Applications for this Company
Contact AUDE PETITJEAN
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 07/17/2015
Decision Date 10/15/2015
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