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 densitometer, bone
510(k) Number K133664
Device Name ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
Applicant
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN
3030 OHMEDA DRIVE
MADISON,  WI  53718 -6704
Applicant Contact CHRIS PAULIK
Correspondent
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN
3030 OHMEDA DRIVE
MADISON,  WI  53718 -6704
Correspondent Contact CHRIS PAULIK
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/29/2013
Decision Date 05/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-