DTU-ONE Ultrasound Scanner
PMA P980010
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP980010 | Date19 Sep 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Bone sonometer
- PMA Number
- FDA Product Code
- MUA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1180
- Advisory Committee
- Radiology
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The DTU-ONE Ultrasound Scanner is a Bone Sonometer, classified under FDA product code MUA, designed for quantitative ultrasound measurement of the calcaneus (heel bone). It provides T-score results to aid physicians in diagnosing osteoporosis and assessing fracture risk in men and women, with additional utility in detecting conditions affecting bone density in Caucasian women.
This device is intended for use in radiology settings and operates as a single-use or reusable system, depending on manufacturer instructions. It is approved under FDA PMA (P980010) and requires adherence to regulatory standards for ultrasound imaging. The scanner measures broadband ultrasound attenuation (BUA) and includes high-resolution imaging capabilities for precise calcaneus assessment. Storage and handling follow manufacturer guidelines to maintain performance.
Other devices from Osteometer Meditech A/S
Questions
AI-generated answers, 18 Sep 2026
What clinical conditions can the DTU-ONE Ultrasound Scanner help assess, and who is it primarily intended for?
The DTU-ONE is designed to measure bone density in the calcaneus (heel bone) using quantitative ultrasound, primarily to aid in diagnosing osteoporosis and evaluating fracture risk in both men and women. It also provides T-score results to help detect conditions affecting bone density in Caucasian women beyond age-related bone loss. The device is not intended for general bone density screening but rather as a supplementary tool alongside clinical risk factors.
How is the DTU-ONE Ultrasound Scanner supplied, and can it be reused?
The DTU-ONE can be used either as a single-use or reusable system, depending on the manufacturer’s instructions. Reuse requires adherence to specific cleaning and maintenance protocols to ensure accuracy and sterility. The device is classified under FDA product code MUA and is intended for use in radiology settings, where proper handling and storage are critical to maintaining performance.
What specific measurements does the DTU-ONE perform, and how does it contribute to clinical decision-making?
The DTU-ONE measures broadband ultrasound attenuation (BUA) of the calcaneus and provides high-resolution imaging to assess bone density. These measurements generate T-scores, which physicians use alongside other clinical risk factors to diagnose osteoporosis and evaluate fracture risk. The results help identify conditions causing reduced bone density in Caucasian women, aiding in targeted medical interventions.
What regulatory pathway does the DTU-ONE follow, and what does this mean for its use in clinical settings?
The DTU-ONE Ultrasound Scanner was approved via the FDA’s Premarket Approval (PMA) process under PMA number P980010. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use—quantitative ultrasound measurement of the calcaneus to aid in osteoporosis diagnosis and fracture risk assessment. Clinicians should follow FDA and manufacturer guidelines to ensure proper implementation in radiology settings.