PMA · Approved
Recalled · 2009Siemens Mammomat Novationdr Full Field Digital Mammography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solution · MUE Full Field Digital, System, X-Ray, Mammographic
Approved on Aug 20, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 498-day review. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 20, 2004
- Review
- 498 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 2
31 later devices descend from it, 6 citing it directly.
- This deviceP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004
- Descendant · cites it directly · 7 of its ownK123520 Mammomat Inspiration PrimeSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · cites it directly · 7 of its ownK042868 Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 2 generations on · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · cites it directly · 5 of its ownK110729 Aspire HD Full-Field Digital Mammography SystemFujifilm Medical Systems U.S.A, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 4 of its ownK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K123520Mammomat Inspiration PrimeSiemens Medical Solutions USA, Inc. · 2013 · cites it directly7descendants
- K042868Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc. · 2005 · cites it directly7descendants
- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · 2 generations on6descendants
- K110729Aspire HD Full-Field Digital Mammography SystemFujifilm Medical Systems U.S.A, Inc. · 2011 · cites it directly5descendants
- K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | — |
| +1 | K123520 | Mammomat Inspiration Prime | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| +1 | K042868 | Mammoreport Softcopy Workstation | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +2 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| +1 | K110729 | Aspire HD Full-Field Digital Mammography System | Fujifilm Medical Systems U.S.A, Inc. | 2011 | 3 |
| +3 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 MUE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUE device
- #1 K253678 MAMMOMAT B.brilliant (11372950)score 13.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (31)
See all 316 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2009 | Not classified | Z-1233-2009 | Software design | Image may appear dark, requiring repeat image acquisition. |
| May 25, 2005 | Not classified | Z-1045-05 | Other | potential issue (image acquisition may become interrupted) when using multiple network nodes |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123520 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MUE devicesMUE Full Field Digital, System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUE
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUE
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUE
40in 2025
MAUDE reports naming product code MUE, 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 | 6 | — | 0 | 0 |
| 2008 | 5 | — | 1 | 4 |
| 2009 | 8 | — | 1 | 3 |
| 2010 | 10 | — | 2 | 2 |
| 2011 | 10 | 192 | 5 | 10 |
| 2012 | 4 | 123 | 0 | 6 |
| 2013 | 7 | 207 | 0 | 11 |
| 2014 | 1 | — | 2 | 7 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 19 |
| 2017 | 8 | 95 | 6 | 115 |
| 2018 | 2 | — | 1 | 145 |
| 2019 | 2 | — | 1 | 80 |
| 2020 | 4 | 188 | 0 | 49 |
| 2021 | 4 | 164 | 0 | 25 |
| 2022 | 3 | 404 | 0 | 36 |
| 2023 | 1 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 3 | 255 | 4 | 40 |
| 2026 | 4 | 185 | 1 | — |
https://510kreport.com/device/P030010 · printed Nov 4, 2026
Cite this page
510(k) Report. “P030010: Siemens Mammomat Novationdr Full Field Digital Mammography System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P030010
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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