GE Medical Systems (China) Co.,Ltd. v1 Achilles EXPII

"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

Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41. Compartment for gel bottle included.

"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

Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.

Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.

"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