OTE
- Product code
- OTE
- Device name
- Digital Breast Tomosynthesis
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
FDA classification definition
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Official FDA classification page: OTE
Classification and pathway per current FDA publications. Data from openFDA (CC0).