# K161919: UltraScan 650

- Pathway: 510(k) (Traditional)
- Applicant: Cyberlogic, Inc.
- Decided: Apr 5, 2017 after 266 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: 2 generations back to P970040 (1998). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103633: Achilles, Ge Medical Systems China Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K180516: EchoS (2018), 2 descendants of its own
- K202514: EchoS Family (2021), 1 descendant of its own
- K212851: EchoSK and EchoSGyn modules for EchoS Family devices (2022), 0 descendants of its own

## Indications for use
UltraScan 650 can be used to determine BMDUS Index in adult men and women and to assess appendicular fracture risk in postmenopausal women. The BMDUS Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2. BMDUS Index is expressed in grams/cm2 and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database. BMDUS Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

Source page: https://510kreport.com/device/K161919
Methodology: https://510kreport.com/methodology