BeamMed

Primary DI
07299012704119
Brand
BeamMed
Company
BEAMMED LTD
Model
OMNISENSE 7000 ULTRASOUND BONE SONOMETER
Device description
"""Omnisense 7000:The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. It is comprised of a Main Unit and small hand held probes, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia.Reference databases are provided for measurements at each of the skeletal sites.Omnisense measures SOS utilizing a technology based on well established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated.Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Omnisense reports the bone SOS, together with the T-score (units of standard deviations relative to population reference values of healthy young adults), Z-score values (units of standard deviations relative to age and gender matched population reference values), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Omnisense may report the Osteoporosis, Risk Index (ORI™), which combines the individual results into a single clinical index.No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device.Probes:Omnisense is a multiple skeletal sites. The probes designed to support measurement at the following areas:• CM probe - used for bone strength assessment at the radius and tibia• CS probe - used for bone strength assessment at the phalanx• CR probe - used for bone strength assessment at the metatarsalThe probes can be supplied with Omnisense 7000 and/or Omnisense 8000.Omnisense models:S – Adult applicationP – Pediatric application Premier - Premature"
Published
2017-01-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
MUABone Sonometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUABone SonometerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990035000THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETERBeam-Med, Ltd.2000-01-20MUA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07299012704119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07299012704119072990127041197299012704119

GMDN Terms#

Term, Definition table
TermDefinition
Bone absorptiometric ultrasound systemAn assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ultrasound beam to an anatomical region of interest. Information obtained from detection and analysis of resulting echoes is used in calculations to estimate bone mineral density or subcutaneous fat, or to make other quantitative assessments (e.g., fracture risk). It typically incorporates an ultrasound transducer, detection electronics, a control panel, a computer, software programs, a video display, and a patient positioning system (PPS).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534155155
Device count
1
Lot or batch
true
Serial number
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
72990012704126BeamMedPLATFORM FORCE-MEASURING2017-01-25
07290012704109BeamMedSunlight MiniOmni Ultrasound Bone Sonometer2017-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052461860053Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860060Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860084Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860091Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
06430065790068Bindex BI-2 KitBone Index Finland OyMUA2024-02-01
08052461860046Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-05
08052461860022Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-04
08052461860039Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-04
08052461860008Echolight S.p.a.ECHOLIGHT SPAMUA2019-11-25
08052461860015Echolight S.p.a.ECHOLIGHT SPAMUA2019-11-25
06430065790051Bindex BI-2 KitBone Index Finland OyMUA2018-01-03
06430065790037Bindex BI-2 KitBone Index Finland OyMUA2017-05-31
06430065790044Bindex BI-2 KitBone Index Finland OyMUA2017-05-31
07290012704109BeamMedBEAMMED LTDMUA2017-01-25
06430065790006BindexBone Index Finland OyMUA2017-01-16
06430065790013BindexBone Index Finland OyMUA2017-01-16
00840682116978Achilles EXPIIGE Medical Systems (China) Co.,Ltd.MUA2016-06-27