Clinical Validation Summary

UltraScan 650 — FDA‑Approved, Radiation‑Free Bone Densitometry with DXA‑Equivalent Accuracy

Overview

UltraScan 650 is an FDA‑approved ultrasound bone densitometer designed for fast, radiation‑free assessment of bone mineral density (BMD). Its accuracy and reproducibility have been validated through multiple clinical studies comparing UltraScan 650 measurements with gold‑standard DXA results.

Direct BMD Measurement Using NTD Technology

UltraScan 650 uses CyberLogic’s patented Net Time Delay (NTD) ultrasound technology. Unlike traditional QUS devices that estimate bone quality indirectly, NTD enables direct measurement of bone mineral density, producing results that correlate strongly with DXA.

Direct BMD measurement
High signal stability
Low operator dependency
Strong correlation with DXA BMD, T‑scores and Z-scores
High reproducibility

Clinical Accuracy Compared to DXA

Multiple clinical studies have shown that UltraScan 650 provides DXA‑equivalent accuracy for forearm‑site bone density assessment.

Strong correlation with DXA BMD
High sensitivity for detecting low bone density
High specificity for identifying normal bone density
Consistent performance across age groups and genders

Reproducibility & Precision

UltraScan 650 exhibits excellent reproducibility, making it reliable for follow‑up measurements and long‑term monitoring.

Low coefficient of variation (CV)
High intra‑operator reproducibility
High inter‑operator reproducibility
Stable measurements in mobile screening environments

Radiation‑Free Screening

UltraScan 650 uses no ionizing radiation, making it ideal for primary care, women’s health, endocrinology, preventive medicine, and mobile screening programs.

Clinical Use Cases

Primary care osteoporosis screening
Endocrinology and metabolic bone clinics
Women’s health and menopause centers
Preventive medicine and community screening
Occupational health monitoring

Summary of Published Evidence

UltraScan 650’s clinical performance is supported by:

Peer‑reviewed journal articles
Independent validation studies
Comparative studies with DXA
Technical papers on NTD ultrasound modeling
Longitudinal monitoring studies

Full list of publications:

View Clinical References

UltraScan 650 vs Traditional QUS Devices

Feature	UltraScan 650	Traditional QUS
Measurement Type	Direct BMD (g/cm²)	Indirect estimate
Accuracy	DXA‑equivalent	Lower correlation
Technology	Patented Net Time Delay (NTD)	Broadband ultrasound
Radiation	None	None

Full comparison:

Compare UltraScan 650 vs MiniOmni

Request Clinical Documentation

If your clinic or research group requires validation papers, technical specifications, workflow guides, or comparison data, please contact us.

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