FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Digital Breast Tomosynthesis
PMA: P140011
·
Supplement: S006
·
Decision Dec 10, 2019
Classifications
1
FEI Numbers
20
Registration Numbers
20
Basic Information
- Device Name
- Digital Breast Tomosynthesis
- Trade Name
- MAMMOMAT Revelation with Tomosynthesis Option
- PMA Number
- P140011
- Supplement Number
- S006
- 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
- December 10, 2019
- Date Received
- September 12, 2019
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for changes to the detector software and the tomosynthesis reconstruction pipeline.
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 |