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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSUNLIGHT OMNISENSE BONE SONOMETER
Classification Namebone sonometer
Generic Nameultrasound bone sonometer
Regulation Number892.1180
ApplicantSUNLIGHT MEDICAL LTD.
PMA NumberP990035
Supplement NumberS006
Date Received11/01/2002
Decision Date04/24/2003
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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.
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