|
Device |
digital breast tomosynthesis |
Definition |
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer. |
Product Code | OTE |
Device Class |
3
|
Premarket Approvals (PMA) |
2019 |
2020 |
2021 |
2022 |
2023 |
2024 |
4
|
2
|
1
|
0
|
1
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Hologic, Inc. |
II |
Feb-21-2023 |
|
|
|
|