# K070999: BC (Body Composition Software)

- Pathway: 510(k) (Traditional)
- Applicant: Rjl Systems, Inc.
- Decided: Aug 2, 2007 after 115 days
- Product code: MNW (Analyzer, Body Composition)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K830292 (1983). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862383: Modified Model Bia-103 Body Composition Analyzer, Rjl Systems, Inc. (1987) Summary page 1.
- K050395: Impedimed - Body Composition Analysis, Impedimed Pty, Ltd. (2005) Summary page 1.
- K002835: Bodystat, Bodystat, Ltd. (2001) Summary page 1.

## Most influential descendants
- K103026: Electro Sensor -Body Composition (2011), 0 descendants of its own

## Indications for use
BC is a software accessory for RJL Systems Quantum-Il, Quantum-X, Quantum Desktop, and Quantum-Ill. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-Ill 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.

Source page: https://510kreport.com/device/K070999
Methodology: https://510kreport.com/methodology