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 K113758
Device Name VOLUSON E6/E8/E8EXPERT/E10
Applicant
GE Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
NEU  
Date Received12/21/2011
Decision Date 01/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-