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 K110595
Device Name 4D SONO-SCAN 1.0
Applicant
Tomtec Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE D-85716
Applicant Contact INGE SCHEIDT
Correspondent
Tomtec Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE D-85716
Correspondent Contact INGE SCHEIDT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/02/2011
Decision Date 04/07/2011
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
-
-