Data / Medical devices / Digital Breast Tomosynthesis
Digital Breast Tomosynthesis (OTE): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Digital Breast Tomosynthesis (product code OTE, Class 3). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OTE
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Japan | 2 |
| France | 1 |
| Germany | 1 |
Makers of Digital Breast Tomosynthesis
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems SCS | Buc, France | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Medsource Parts, LLC | Boulder, CO, United States | Remanufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Siemens Medical Solutions Usa, Inc. | Hoffman Estates, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.