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

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSUNLIGHT OMNISENSE BONE SONOMETER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantBEAM-MED LTD
8 HALAPID STR.
PETACH TIKVA 49170
PMA NumberP990035
Supplement NumberS006
Date Received11/01/2002
Decision Date04/24/2003
Reclassified Date 08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE MANAGEMENT MODULE "SUNLIGHT DESKTOP" (SLD). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNLIGHT DESKTOP, SLD AND IS AN ADD-ON TO THE OMNISENSE SOFTWARE THAT WILL FUNCTION AS AN INDEPENDENT APPLICATION. THE SUNLIGHT DESKTOP SOFTWARE ENABLES THE USER TO SHUT DOWN THE OMNISENSE SOFTWARE LEAVING THE PC SYSTEM OPERATING, SO THAT THE USER CAN THEN INITIATE ANY OTHER INSTALLED SOFTWARE (PER THE SOFTWARE MANUFACTURER REQUIREMENTS, WHICH WILL OPERATE INDEPENDENT OF THE OMNISENSE SOFTWARE. THIS WILL ALLOW THE USE OF SEVERAL DEVICES WITH THE CONTROL OF ONE PC.
-
-