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 K081018
Device Name SYNGO DYNAMICS VERSION 7.0
Applicant
SIEMENS MEDICAL SOLUTIONS
400 WEST MORGAN RD., SUITE 100
ANN ARBOR,  MI  48108
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/10/2008
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
-
-