UBIS 5000 Bone Sonometer
by Diagnostic Medical Systems PMA
Active
PMA P000055
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP000055 | Date17 Jul 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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 UBIS 5000 Bone Sonometer is a quantitative ultrasound (AUS) device classified as a bone sonometer. It measures broadband ultrasound attenuation (BUA) of the calcaneus to aid in diagnosing osteoporosis and assessing the risk of subsequent atraumatic fractures, providing results in BUA and T-score formats.
This device is used in radiology settings for clinical assessment and is supplied as a reusable medical instrument. It operates under FDA approval (PMA P000055) and adheres to regulatory standards for Class II devices (regulation number 892.1180). No specific sterility or single-use designation is noted in the data.
Other devices from Diagnostic Medical Systems
Questions
AI-generated answers, 18 Sep 2026
What clinical purpose does the UBIS 5000 Bone Sonometer serve in a radiology setting?
The UBIS 5000 Bone Sonometer is designed to measure broadband ultrasound attenuation (BUA) of the heel bone (calcaneus) using quantitative ultrasound technology. It aids clinicians in diagnosing osteoporosis and estimating the risk of future atraumatic fractures by providing results in both BUA and T-score formats, helping guide patient management.
Is the UBIS 5000 Bone Sonometer intended for single-use or reusable applications?
The UBIS 5000 Bone Sonometer is supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients after proper cleaning and maintenance. There is no indication in the data that it requires single-use disposal.
What regulatory approval pathway does the UBIS 5000 Bone Sonometer follow, and what classification does it hold?
The UBIS 5000 Bone Sonometer follows the FDA’s Premarket Approval (PMA) pathway, with approval granted under PMA number P000055. It is classified as a Class II device under regulation number 892.1180, which aligns with its role as a quantitative ultrasound bone sonometer for diagnostic purposes.
Does the UBIS 5000 Bone Sonometer include any specific sterility requirements or designations?
The provided data does not specify any sterility requirements or single-use designation for the UBIS 5000 Bone Sonometer. Since it is reusable, proper cleaning and maintenance protocols would be necessary to ensure safe, repeated use across patients.
What types of measurements does the UBIS 5000 Bone Sonometer provide, and how are they presented?
The UBIS 5000 Bone Sonometer provides two key measurements: broadband ultrasound attenuation (BUA) of the calcaneus and a T-score. These results are presented to clinicians to aid in diagnosing osteoporosis and assessing fracture risk, offering quantitative data for clinical decision-making.