FDA product code OTE: Digital Breast Tomosynthesis
OTE is the FDA product code for digital breast tomosynthesis. It is a Class III device, reviewed by the Radiology panel. Devices under OTE reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 5 recalls for OTE devices, 4 initiated in the last five years.
Definition
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Classification
| Field | Value |
|---|---|
| Device name | Digital Breast Tomosynthesis |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OTE devices
5 product recalls in 5 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-04-08.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0279 — Diagnostic digital breast tomosynthesis, unilateral or bilateral (list separately in addition to 77065 or 77066)
Frequently asked questions
What is FDA product code OTE?
OTE is the FDA product code for digital breast tomosynthesis. It is a Class III device, reviewed by the Radiology panel.
What device class is OTE?
Class III. Typical premarket route: PMA.
Have OTE devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2026-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code OTE
- Run a recall and safety report across every OTE manufacturer
- Watch product code OTE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times