• 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 K153351
Device Name Quantib Brain 1
Applicant
QUANTIB BV
WESTBLAAK 106
ROTTERDAM,  NL NL-3012 KM
Applicant Contact FLOOR VAN LEEUWEN
Correspondent
QUANTIB BV
WESTBLAAK 106
ROTTERDAM,  NL NL-3012 KM
Correspondent Contact FLOOR VAN LEEUWEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/20/2015
Decision Date 06/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-