2 devices · 2 companies · 2024 to 2025
Product code OTE: Digital Breast Tomosynthesis
2 devices under product code OTE, 2024 to 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (0 of 2 here), the regulation, and MAUDE report counts by product code.
Digital Breast Tomosynthesis. To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer. MAUDE held 1,032 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Senographe Pristina 3DP130020/S005 · PMA | GE Healthcare | Radiology | database entry | |
| MAMMOMAT B.brilliant with Tomosynthesis OptionP140011/S008 · PMA | SIEMENS MEDICAL SOLUTIONS USA, INC. | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.