FDA product code · Radiology
Digital Breast Tomosynthesis
4 FDA decisions since 2011. 2 recalls name this code, 0 of them Class I.
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OTE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · OTE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OTE
Too few OTE 510(k)s in any year since 2007 to give a median.
Recalls per year · OTE
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTE
139in 2025
MAUDE reports naming product code OTE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 3 | — | 1 | 18 |
| 2017 | 8 | — | 0 | 166 |
| 2018 | 2 | — | 0 | 87 |
| 2019 | 4 | — | 0 | 80 |
| 2020 | 2 | — | 0 | 37 |
| 2021 | 1 | — | 0 | 40 |
| 2022 | 0 | — | 0 | 58 |
| 2023 | 1 | — | 0 | 59 |
| 2024 | 3 | — | 0 | 130 |
| 2025 | 2 | — | 0 | 139 |
| 2026 | 1 | — | 1 | — |
Planning a device in OTE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report