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 K113356
Device Name HOLOGIC VISCERAL FAT SOFTWARE
Applicant
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Applicant Contact EILEEN M BOYLE
Correspondent
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact EILEEN M BOYLE
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/14/2011
Decision Date 03/06/2012
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
-
-