SUNLIGHT OMNISENSE BONE SONOMETER

Bone Sonometer

FDA Premarket Approval P990035 S006

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.

Pre-market Approval Supplement Details

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.

DeviceSUNLIGHT OMNISENSE BONE SONOMETER
Classification NameBone Sonometer
Generic NameBone Sonometer
ApplicantBEAM-MED LTD
Date Received2002-11-01
Decision Date2003-04-24
PMAP990035
SupplementS006
Product CodeMUA
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BEAM-MED LTD 8 Halapid Str. petach Tikva 49170

Supplemental Filings

Supplement NumberDateSupplement Type
P990035Original Filing
S006 2002-11-01 Normal 180 Day Track
S005 2001-12-21 Normal 180 Day Track
S004 2001-09-25 Normal 180 Day Track
S003 2001-08-10 Normal 180 Day Track
S002 2001-06-26 Normal 180 Day Track
S001 2000-06-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
07299012704119 P990035 000
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