Qus-2 (tm) Calcaneal Ultrasonometer
FDA PMAClass III (US FDA PMA)
by Quidel Corp.
Identity
- Trade Name
- QUS-2 (TM) CALCANEAL ULTRASONOMETER FDA PMA
- Generic Name
- Tester, acoustic, bone quality FDA PMA
Identifiers
- PMA Number
- P990039 FDA PMA
- FDA Product Code
- NAN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APWD FDA PMA
The QUS-2 Calcanel Ultrasonometer is a quantitative ultrasound device designed for evaluating bone quality in the calcaneus. It measures broadband ultrasound attenuation (BUA) to aid in diagnosing osteoporosis and assessing the risk of subsequent atraumatic fractures.
This device is supplied as a reusable medical instrument and is intended for use in radiology settings. Authorized for FDA approval under PMA number P990039, it operates under Class III regulatory classification and is not indicated for MRI environments. Storage and handling follow standard medical device protocols as per manufacturer guidelines.
Frequently asked questions
What clinical condition is the QUS-2 Calcanel Ultrasonometer primarily used to evaluate, and how does it do so?
The QUS-2 is designed to evaluate bone quality in the calcaneus (heel bone) to aid in diagnosing osteoporosis and assessing the risk of future atraumatic fractures. It achieves this by measuring broadband ultrasound attenuation (BUA), a quantitative ultrasound metric that helps quantify bone density and structural integrity.
Is the QUS-2 Calcanel Ultrasonometer intended for single-use or reusable applications, and where should it be used?
The QUS-2 is supplied as a **reusable** medical instrument and is intended exclusively for use in radiology settings. Since it is not designed for MRI environments, it should only be operated in facilities equipped with standard radiology equipment, not near magnetic resonance imaging systems.
How is the QUS-2 Calcanel Ultrasonometer regulated, and what does that mean for its use in clinical practice?
The QUS-2 is classified as a **Class III** medical device under FDA regulations and was approved via a **Premarket Approval (PMA)** application (PMA #P990039). This means it underwent rigorous review by the FDA’s Radiology Devices Advisory Committee (RA) to ensure its safety and effectiveness for diagnosing osteoporosis and fracture risk assessment, as outlined in the approval order.
What storage and handling guidelines should be followed for the QUS-2 Calcanel Ultrasonometer?
While specific storage instructions are manufacturer-dependent, the QUS-2, like all reusable medical devices, should be handled according to **standard medical device protocols** as recommended by Quidel Corp. This typically includes cleaning, disinfection, and proper storage to maintain functionality and sterility between uses, though the device itself is not described as sterile.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990039 | Class III | Active |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA PMA P990039 24 fields · synced Sep 18, 2026