510(k) · Cleared
ClearedMammomat Fusion with Stereotactic Biopsy
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 Jan 10, 2017 as substantially equivalent to K122286 (Siemens Medical Solutions USA, Inc., 2013) and 1 other predicate after a 53-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jan 10, 2017
- Review
- 53 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P030010 (2004). 4 ancestors in all, the oldest P990066 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- 2 generations backK122286 Mammomal InspirationSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 1 generation backK151645 MAMMOMAT FusionSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- This deviceK163252 Mammomat Fusion with Stereotactic BiopsySiemens Medical Solutions USA, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| −2 | K122286 | Mammomal Inspiration | Siemens Medical Solutions USA, Inc. | 2013 | 5 |
| −1 | K151645 | MAMMOMAT Fusion | Siemens Medical Solutions USA, Inc. | 2015 | 1 |
| 0 (this device) | K163252 | Mammomat Fusion with Stereotactic Biopsy | Siemens Medical Solutions USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K122286 | Mammomal InspirationSummary page 5…Medical Specialty: Radiology Review Panel: Radiology Product Code: MUE Submission Type: 510(k) (K122286, 02/22/2013) Regulation Number: 21 CFR 892.1715 Device Class: 2 Reference p… | 2013 |
| * | K151645 | MAMMOMAT FusionSummary page 5…Medical Specialty: Radiology Review Panel: Radiology Product Code: MUE Submission Type: 510(k) (K151645, 09/14/2015) Regulation Number: 21 CFR 892.1715 Device Class: 2 5. Device Descrip… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K122286.
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. 2017, 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 Fusion system generates digital mammographic images that can be used for screening, diagnosis and stereotactic biopsies of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163252 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163252: Mammomat Fusion with Stereotactic Biopsy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163252
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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