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 system, image processing, radiological
510(k) Number K162008
Device Name JiveX
Applicant
VISUS TECHNOLOGY TRANSFER GMBH
Universitaetsstrasse 136
bochum,  DE 44799
Applicant Contact axel schreiber
Correspondent
VISUS TECHNOLOGY TRANSFER GMBH
Universitaetsstrasse 136
bochum,  DE 44799
Correspondent Contact axel schreiber
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/20/2016
Decision Date 09/16/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-