FDA PMA
FDA Class 2
Approved (Reclassification)
🇺🇸 United States
Bone Sonometer
PMA: P990016
·
Decision Jan 7, 2000
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0
- PMA Number
- P990016
- Device Class
- FDA Class 2
- Product Code
- MUA
- Generic Name
- Bone sonometer
- Regulation Number
- 892.1180
- Medical Specialty
- Radiology
- Advisory Committee
- Radiology
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- January 7, 2000
- Date Received
- March 8, 1999
- Expedited Review
- N
- Docket Number
- 00M-0580
Advisory Committee Statement
Approval to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid for the diagnosis of osteoporosis and other medical conditions leading to reduced bone density and, ultimately, for the determination of fracture risk.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUA | Bone Sonometer | FDA class 2 | Radiology |