PMA · Approved
Recalled · Class II · 2026Selenia Dimensions Full Field Digital Mammography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OTE Digital Breast Tomosynthesis
Approved on Feb 11, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 1,116-day review. It has been recalled 4 times.
- Decided
- Feb 11, 2011
- Review
- 1,116 days
- Class
- Class III
- Product code
- OTE
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P080003 has 10 supplements since 2013: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OTE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2026 | Class II | Z-2168-2026 | Device Design | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| Aug 19, 2024 | Class II | Z-3248-2024 | Software design | Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and… |
| Jan 16, 2023 | Class II | Z-1144-2023 | Device Design | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual |
| Jan 21, 2020 | Class II | Z-1343-2020 | Process control | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OTE devicesOTE Digital Breast Tomosynthesis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P080003 · printed Nov 6, 2026
Cite this page
510(k) Report. “P080003: Selenia Dimensions Full Field Digital Mammography System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P080003
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026