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 K082317
Device Name GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
Applicant
General Electric Co.
726 Heartland Trl.
Madison,  WI  53717
Applicant Contact JAMES P RASKOB
Correspondent
General Electric Co.
726 Heartland Trl.
Madison,  WI  53717
Correspondent Contact JAMES P RASKOB
Regulation Number892.1170
Classification Product Code
KGI  
Date Received08/13/2008
Decision Date 09/26/2008
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
-
-