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 K981790
Device Name IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW
Applicant
Elekta Oncology Systems, Ltd.
8 Executive Park W.
Suite 809
Atlanta,  GA  30329
Applicant Contact PAUL L SUMNER
Correspondent
Elekta Oncology Systems, Ltd.
8 Executive Park W.
Suite 809
Atlanta,  GA  30329
Correspondent Contact PAUL L SUMNER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/20/1998
Decision Date 08/07/1998
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
Recalls CDRH Recalls
-
-