BeamMed

GUDID 07290012704109

"Sunlight MiniOmni: The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. Sunlight MiniOmni Ultrasound Bone Sonometer is a modified version of company's well- established Sunlight Omnisense systems*. Sunlight MiniOmni is based on the Sunlight Omnipath™ technology already CE marked and approved by the FDA (PMA). It is comprised of a Main Unit and the same hand held probes as used with other BeamMed's Bone Sonometers, 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, Sunlight MiniOmni 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. Sunlight MiniOmni reports the bone SOS, together with the Z-score (units of standard deviations relative to age and gender matched population reference values), for adults also as a T-score values (units of standard deviations relative to population reference values of healthy young adults), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Sunlight No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device. Probes: MiniOmni is a multiple skeletal sites. The probes designed to support measurement at the following areas: • CM probes - used for bone strength assessment at the radius and tibia • CS probe - used for bone strength assessment at the phalanx • CR

BEAMMED LTD

Bone absorptiometric ultrasound system

• Primary Device ID: 07290012704109
• NIH Device Record Key: 99adf171-7682-461d-97d3-37351835d31d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BeamMed
• Version Model Number: Sunlight MiniOmni Ultrasound Bone Sonometer
• Company DUNS: 534155155
• Company Name: BEAMMED LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290012704109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110646

FDA Product Code

• MUA: Bone Sonometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-10
• Device Publish Date: 2017-01-25

On-Brand Devices [BeamMed]

• 07299012704119: "Omnisense 7000: The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultrasound d
• 07290012704109: "Sunlight MiniOmni: The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive ultrasound
• 72990012704126: "Tetrax balance assessment is used to quantitatively detect changes in postural responses that h