De Novo · Granted
GrantedBreastview Visual Mapping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Assurance Medical · NKA System, Documentation, Breast Lesion
Granted on Jan 31, 2003 as a new device type through De Novo after a 248-day review. 3 later devices descend from it.
- Decided
- Jan 31, 2003
- Review
- 248 days
- Class
- Class II
- Product code
- NKA
- Recalls
- None
3 later devices descend from it, 2 citing it directly.
- This deviceDEN020001 Breastview Visual Mapping SystemAssurance Medical · 2003
- Descendant · cites it directly · 1 of its ownK142926 iBreastExamUe Lifesciences, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK190575 iBreastExamUe Lifesciences, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK181672 SureTouch Mobile Pressure Mapping SystemSure, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN020001 | Breastview Visual Mapping System | Assurance Medical | 2003 | — |
| +1 | K142926 | iBreastExam | Ue Lifesciences, Inc. | 2015 | — |
| +2 | K190575 | iBreastExam | Ue Lifesciences, Inc. | 2019 | — |
| +1 | K181672 | SureTouch Mobile Pressure Mapping System | Sure, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKA? 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?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142926 (Ue Lifesciences, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NKA devicesNKA System, Documentation, Breast Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKA
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · NKA
Too few NKA 510(k)s in any year since 2007 to give a median.
Recalls per year · NKA
No recall names NKA since 2007.
Adverse event reports per year · NKA
No MAUDE report names NKA since 2007.
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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN020001 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN020001: Breastview Visual Mapping System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN020001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026