OTE · Digital Breast Tomosynthesis
· Class 3
Overview
| Product Code | OTE |
|---|---|
| Device Name | Digital Breast Tomosynthesis |
| Device Class | Class 3 |
| Review Panel |
Identification
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160031 | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION | Fujifilm Medical Systems U.S.A, Inc. | Jan 10, 2017 | APPR |
| P140011 | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION | Siemens Medical Solutions USA, Inc. | Apr 21, 2015 | APPR |
| P130020 | SENOCLAIRE | GE Healthcare | Aug 26, 2014 | APPR |
| P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | Feb 11, 2011 | APPR |
Top Applicants
- Fujifilm Medical Systems U.S.A, Inc. — 1 clearance
- GE Healthcare — 1 clearance
- Hologic, Inc. — 1 clearance
- Siemens Medical Solutions USA, Inc. — 1 clearance
