510(k) · Cleared
ClearedMAMMOMAT B.brilliant (11372950)
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 Jun 18, 2026 as substantially equivalent to K233539 (Siemens Medical Solutions USA, Inc., 2024) after a 209-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jun 18, 2026
- Review
- 209 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K941191 (1995). 16 ancestors in all, the oldest K921962 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- 7 generations backK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- 6 generations backK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- 5 generations backK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- 4 generations backK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- 3 generations backK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- 2 generations backK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK233539 MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024
- This deviceK253678 MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| −7 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| −6 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| −5 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| −4 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| −3 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| −2 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −1 | K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024 | — |
| 0 (this device) | K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 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 K254090 I-View®score 12.5 · 3 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 |
|---|---|---|---|
| * | K233539 | MAMMOMAT B.brilliantSummary page 6…oduct Code: MUE 4. Legally Marketed Predicate Device Trade Name: MAMMOMAT B.brilliant 510(k) #: K233539 Classification Name: Full Field Digital, System, X-Ray Mammographic Classification Panel: Radiology Cla… | 2024 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 7 of the 16 ancestors have a recall of any class.
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. 2026, 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 digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. Mammography images can be interpreted by either hard copy film or soft copy workstation.
With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253678: MAMMOMAT B.brilliant (11372950).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253678
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026