FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Digital Breast Tomosynthesis
PMA: P130020
·
Supplement: S005
·
Decision Nov 21, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Digital Breast Tomosynthesis
- Trade Name
- Senographe Pristina 3D
- PMA Number
- P130020
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- OTE
- Generic Name
- Digital breast tomosynthesis
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 21, 2025
- Date Received
- April 21, 2025
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for Senographe Pristina 3D that includes an update to the DBT reconstruction algorithm to enhance image quality using deep learning algorithms to correct sparse view artifacts, compensate for patient motion artifacts and enhance the visibility of soft tissue lesions within the 2D synthetic image.
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 |
|---|---|---|---|
| OTE | Digital Breast Tomosynthesis | FDA class 3 | Unknown |