BeamMed

"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…

Registry build 21.09.26

“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 metatarsal The probes can be supplied with Omnisense 7000 and/or Omnisense 8000. Omnisense models: S → Adult application P → Pediatric application Premier – Premature

1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code MUA
Manufacturer City Province Registered as Device types
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57

Record

Regulatory record for BeamMed
Listed by BeamMed Ltd., Israel
FDA product code MUA
Device type Bone Sonometer
Device class Class 2
Regulation 21 CFR 892.1180
Establishment Manufacturer
510(k) K110646
Record published 2017-01-25
Record revised 2020-07-08 (version 5)

Specifications

Specifications
MRI safety MR Unsafe
Label carries lot or batch number, serial number
Distribution end date 2020-07-07

Catalogue Numbers

Catalogue numbers for BeamMed
Catalogue number Size Status
Sunlight MiniOmni Ultrasound Bone Sonometer In distribution
OMNISENSE 7000 ULTRASOUND BONE SONOMETER Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Echolight S.p.a. Echolight SPA 9
Bindex BI-2 Kit Bone Index Finland Ltd. 4
Bindex Bone Index Finland Ltd. 2
Achilles Expii GE Medical Systems (China) Co., Ltd. 1

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number Decision Trade name Approved to
P010058 2004-03-15 OSTEOSPACE Medilink
P990035 2001-11-30 SUNLIGHT OMNISENSE 7000S Beam-Med, Ltd.
P000055 2001-07-17 UBIS 5000 BONE SONOMETER Diagnostic Systems
P980010 2000-09-19 DTU-ONE ULTRASOUND SCANNER Osteometer Meditech A/S
P990016 2000-01-07 MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 Coopersurgical, Inc.
P970017 1999-04-29 HOLOGIC SAHARA CLINICAL BONE SONOMETER Hologic, Inc.
P970040 1998-06-26 ACHILLES EXPRESS ULTRASONOMETER Ge Lunar Corp.
P970026 1998-05-29 MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN Myriad Ultrasound Systems, Ltd.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer