• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name system, image processing, radiological
510(k) Number K170172
Device Name UNiD Spine Analyzer
5389 Route de Strasbourg-Vancia
Rillieux La Pape,  FR 69140
Applicant Contact David Ryan
Hogan Lovells US LLP
5389 Route de Strasbourg - Vancia
Rillieux La Pape,  FR
Correspondent Contact David Ryan
Regulation Number892.2050
Classification Product Code
Date Received01/19/2017
Decision Date 05/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No