# K123238: Achilles

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: Feb 25, 2013 after 132 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Achilles EXP II: named in the summary without a submission number

## Indications for use
Achilles OsteoReportN is software used with the Achilles family of ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems. Achilles OsteoReportN together with the Achilles ultrasonometers 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 conmparable 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 mn the same way as aref.-scores or obtained by x-ray absorptiometry. 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/K123238
Methodology: https://510kreport.com/methodology