510(k) · Cleared
Recalled · Class II · 2017Mammomal Inspiration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Feb 22, 2013 as substantially equivalent to P030010 (Siemens Medical Solution, 2004) after a 207-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Feb 22, 2013
- Review
- 207 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to P030010 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- This deviceK122286 Mammomal InspirationSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK151645 MAMMOMAT FusionSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK163252 Mammomat Fusion with Stereotactic BiopsySiemens Medical Solutions USA, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| 0 (this device) | K122286 | Mammomal Inspiration | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K151645 | MAMMOMAT Fusion | Siemens Medical Solutions USA, Inc. | 2015 | 1 |
| +1 | K163252 | Mammomat Fusion with Stereotactic Biopsy | Siemens Medical Solutions USA, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography SystemSummary page 2…tube on the top end and the object table with the detector on the bottom end. The Mammomat Inspiration was submitted as a supplement (S006) to PMA P03001 0. This supplement was approved on November 05, 2010. All Full Field Digital Mammography (FFDM) systems were reclassi… | 2004 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2017 | Class II | Z-1118-2017 | Software design | Software error |
| Oct 28, 2014 | Class II | Z-0523-2015 | Use error | It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table… |
| Sep 18, 2014 | Class II | Z-0086-2015 | Process control | The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety… |
| Apr 25, 2014 | Class II | Z-1638-2014 | Device Design | There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury. |
| Feb 28, 2013 | Class II | Z-1694-2013 | Device Design | Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis,
and stereotactic biopsies under supervision of medical professionals.
Mammographic images can be interpreted by either hardcopy film or softcopy workstation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122286 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122286: Mammomal Inspiration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122286
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026