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510(k) Data Aggregation
K Number
K070999Device Name
BC (BODY COMPOSITION SOFTWARE)
Manufacturer
RJL SYSTEMS, INC.
Date Cleared
2007-08-02
(115 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
RJL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BC is a software accessory for RJL Systems Quantum-X, Quantum Desktop, and Quantum-III. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-III analyzers, the computer must have an available serial port.
Indications for Use:
Calculation and Historical Tracking of:
- Actual Impedance .
- Actual Phase Angle (PA) .
- Estimated Body Fat (FAT) .
- Estimated Fat Free Mass (FFM) .
- . Estimated Total Body Water (TBW)
- Estimated Intra-Cellular Water (ICW) ●
- Estimated Extra-Cellular Water (ECW) ●
- Estimated Basal Metabolic Rate (BMR) .
- Estimated Daily Energy Expenditure (DEE) .
- Actual Body Mass Index (BMI) .
BC is intended only for use on normally healthy adults and adolescents age 9-94.
Device Description
The BC application is intended to be used as a software accessory to RJL Systems' existing line of Bio-Impedance Analyzers ( K830292 and K862383 ). The user obtains values for the Resistance and Reactance of an individual, and enters these numbers, along with the individual's name, age, height, weight, gender, activity level, frame size, and optionally, subject ID and desired target weight. These values are stored in a database to enable historical tracking, and are then used in a series of prediction equations to estimate the parameters listed above.
For estimating body composition parameters, the BC application relies on prediction equations developed as the result of clinical studies. The user is provided the opportunity to select from several different sets of equations, each assembled from one or more studies. References are provided for every set of equations, except for those contained in the original RJL BIA-103 device software.
The BC application is non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition.
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