Identity
- Trade Name
- SENOCLAIRE FDA PMA
- Generic Name
- Digital breast tomosynthesis FDA PMA
Identifiers
- PMA Number
- P130020 FDA PMA
- FDA Product Code
- OTE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Senoclaire is a digital breast tomosynthesis system designed for the acquisition of 2D images and multiple projection views to produce 3D DBT images. It is indicated for the screening and diagnosis of breast cancer and can be utilized for the same clinical applications as traditional mammography. The system supports various examination configurations, including craniocaudal and mediolateral oblique views.
This device is an option for the Senographe Essential FFDM system and may be used for additional diagnostic workup of the breast. It has received FDA PMA authorization for its intended clinical use. The system is designed to integrate into standard radiology workflows for both screening and diagnostic imaging procedures.
Frequently asked questions
What is the primary function of the Senoclaire system?
The Senoclaire system is a digital breast tomosynthesis device used to acquire 2D images and multiple projection views to generate 3D images for the screening and diagnosis of breast cancer.
Can Senoclaire be used for standard mammography screenings?
Yes, Senoclaire is indicated for the same clinical applications as traditional mammography, allowing it to be used for screening examinations consisting of specific 2D and 3D image sets.
Is Senoclaire a standalone device?
No, the Senoclaire digital breast tomosynthesis option is designed to be used with the Senographe Essential FFDM system to provide enhanced imaging capabilities.
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 | P130020 | Class III | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA PMA P130020 24 fields · synced Oct 6, 2026