# K103633: Achilles

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: May 11, 2011 after 149 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 P970040 (1998). 1 ancestor in all.
4 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)
- P970040: Achilles Express Ultrasonometer, Ge Lunar Corp. (1998). The summary prints P970040, a PMA number, which our reading took as K970040. Corrected to the number the summary prints. Summary page 1.

## Most influential descendants
- K161919: UltraScan 650 (2017), 3 descendants of its own
- 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
The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Source page: https://510kreport.com/device/K103633
Methodology: https://510kreport.com/methodology