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 accelerator, linear, medical
510(k) Number K072079
Device Name IGUIDE SYSTEM
Applicant
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
FEYERABENDSTRASSE 13-15
SCHWABMUNCHEN,  DE 86830
Applicant Contact MICHAEL WOLFF
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/30/2007
Decision Date 08/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
-
-