Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 X-Ray, Tomography, Computed, Dental
510(k) Number K151612
Device Name NewTom VGi evo
Applicant
Qr S.R.L.
Via Silvestrini 20
Verona,  IT 37135
Applicant Contact LORENZO BORTOLOTTI
Correspondent
THEMA S.r.l.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact SIMONA DAIDONE
Regulation Number892.1750
Classification Product Code
OAS  
Date Received06/15/2015
Decision Date 03/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-