# K110646: Beammed Sunlight Miniomni Bone Sonometer

- Pathway: 510(k) (Abbreviated)
- Applicant: Beam-Med, Ltd.
- Decided: Oct 12, 2011 after 222 days
- Product code: MUA (Bone Sonometer)
- Device class: 2
- Regulation: 21 CFR 892.1180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P990035 (2000). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P990035: The Sunlight Omnisense (TM) Ultrasound Bone Sonometer, Beam-Med, Ltd. (2000) Summary page 2.

## Most influential descendants
- K180516: EchoS (2018), 2 descendants of its own
- K152020: Bindex BI-100 (2016), 2 descendants of its own
- K202514: EchoS Family (2021), 1 descendant of its own
- K161971: Bindex BI-2 (2017), 1 descendant of its own
- K211350: Bindex BI-2 (2022), 0 descendants of its own

## Indications for use
The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of Ultrasound waves ("Speed of Sound' or "SOS" in rn/seo) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility. The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk. Multiple skeletal site testing provided clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture. The SOS measured by MiniOmni has a precision error low enough in comparison with the, expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).

Source page: https://510kreport.com/device/K110646
Methodology: https://510kreport.com/methodology