SoundScan Bone Sonometer
by Myriad Ultrasound Systems, Ltd.
PMA P970026
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP970026 | Date29 May 1998 | 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- Withdrawn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
- Full name
- Myriad Ultrasound Systems Ltd. Soundscan
- Generic Name
- Bone sonometer
- FDA applicant
- Myriad Ultrasound Systems , Ltd.
- 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 SoundScan Bone Sonometer is a quantitative ultrasound device classified as a bone sonometer, designed to assess skeletal fragility by measuring the speed of sound (SOS) along the tibia. It provides an objective index of bone strength, reporting SOS values alongside T- and Z-scores to aid physicians in evaluating fracture risk and diagnosing conditions associated with reduced bone density.
This device is used in radiology settings to perform non-invasive, exclusive bone measurements unaffected by overlying soft tissue. Supplied as a reusable medical instrument, it operates under FDA Premarket Approval (PMA P970026) and falls under device classification II (regulation number 892.1180). Storage and handling follow standard clinical protocols for ultrasound equipment, with no specific sterility requirements stated beyond general medical device hygiene.
Questions
AI-generated answers, 18 Sep 2026
What clinical conditions can the SoundScan help evaluate, and how does it contribute to patient assessment?
The SoundScan Bone Sonometer is designed to assess skeletal fragility by measuring the speed of sound (SOS) along the tibia, providing an objective index of bone strength. It aids physicians in evaluating fracture risk and diagnosing conditions like osteoporosis or other medical conditions that reduce bone density. The device reports SOS values alongside T- and Z-scores, which help quantify bone strength and guide clinical decisions alongside other risk factors.
Is the SoundScan a single-use or reusable device, and what are the storage requirements?
The SoundScan is a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Storage follows standard protocols for ultrasound equipment, with no specific sterility requirements beyond general medical device hygiene. Proper cleaning and maintenance are essential to ensure accurate measurements and device longevity.
How does the SoundScan differ from other imaging modalities in evaluating bone health?
Unlike traditional imaging techniques (e.g., X-rays or CT scans), the SoundScan performs non-invasive, exclusive bone measurements unaffected by overlying soft tissue. It specifically measures the speed of sound (SOS) along the tibia, providing a direct quantitative assessment of bone strength without radiation exposure or contrast agents. This makes it a unique tool for evaluating skeletal fragility in a radiology setting.
What regulatory pathway does the SoundScan follow, and what does this mean for clinicians?
The SoundScan Bone Sonometer follows the FDA Premarket Approval (PMA) pathway, with approval under PMA number P970026. This means the device has undergone rigorous review to ensure its safety and effectiveness for measuring bone strength via quantitative ultrasound. Clinicians can rely on its validated performance for assessing fracture risk and diagnosing conditions like osteoporosis, as authorized by the FDA.