Search Results
Found 2 results
510(k) Data Aggregation
K Number
K161971Device Name
Bindex BI-2
Manufacturer
BONE INDEX FINLAND, LTD.
Date Cleared
2017-01-09
(175 days)
Product Code
MUA
Regulation Number
892.1180Why did this record match?
Applicant Name (Manufacturer) :
BONE INDEX FINLAND, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.
Device Description
The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bensity at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth.
Ask a Question
K Number
K152020Device Name
Bindex BI-100
Manufacturer
BONE INDEX FINLAND, LTD.
Date Cleared
2016-05-13
(297 days)
Product Code
MUA
Regulation Number
892.1180Why did this record match?
Applicant Name (Manufacturer) :
BONE INDEX FINLAND, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.
Device Description
The Bindex system includes ultrasound pulser, transducer and software. Bindex is connected to the USB port of a computer and controlled with computer software. Bindex is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal (1/3 length) of tibia. Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with disinfective solution moistened cloth or tissue.
Ask a Question
Page 1 of 1