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 K191040
Device Name syngo.via (Version VB40A)
Applicant
Siemens Healthcare GmbH
Siemensstr. 1
Forchheim,  DE 91301
Applicant Contact Elango Alampalayam Rangappan
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact Georg Bauer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/19/2019
Decision Date 05/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-