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, X-Ray, Tomographic
510(k) Number K132261
Device Name DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
Applicant
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact JOHN L SCHMIDT
Correspondent
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact JOHN L SCHMIDT
Regulation Number892.1740
Classification Product Code
IZF  
Date Received07/19/2013
Decision Date 11/18/2013
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
-
-