MC Cue PLC Cuba Clinical Ultrasonic Bone Sonometer System
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 FDA PMA
- Generic Name
- Bone sonometer FDA PMA
Identifiers
- PMA Number
- P990016 FDA PMA
- FDA Product Code
- MUA FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.1180 FDA PMA
- Regulation Number
- 892.1180 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APRL FDA PMA
The MC Cue PLC Cuba Clinical Ultrasonic Bone Sonometer System is a quantitative ultrasound device classified as a bone sonometer. It measures calcaneus (heel bone) density to assess fracture risk, aiding in the diagnosis of osteoporosis and other conditions associated with reduced bone density. The system provides quantitative ultrasound readings that can be integrated with clinical risk factors for diagnostic purposes.
This system is intended for use in radiology settings and is supplied as a reusable medical device. It operates under FDA approval via a Premarket Approval (PMA) and falls under device classification II (MUA product code). The device requires proper calibration and maintenance as specified in its operational manual, with no indication of sterility requirements or MRI compatibility in the provided data.
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 | P990016 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA PMA P990016 24 fields · synced Sep 18, 2026