510(k) · Cleared
Recalled · Class II · 2025MAMMOMAT Revelation
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 12, 2020 as substantially equivalent to K173408 (Siemens Medi Cal Solutions, Inc., 2018) after a 210-day review. Its family tree reaches back 6 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 12, 2020
- Review
- 210 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941191 (1995). 14 ancestors in all, the oldest K921962 (1992). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- 5 generations backK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- 4 generations backK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- 3 generations backK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- 2 generations backK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- 1 generation backK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- This deviceK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK233539 MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253678 MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK210955 Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK210957 Kubec Xpert 80 Radiography SystemKub Technologies, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024 · cites it directly1descendant
- K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026 · 2 generations on0descendants
- K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021 · cites it directly0descendants
- K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| −5 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| −4 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| −3 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| −2 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| −1 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| 0 (this device) | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +1 | K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +2 | K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | 2026 | — |
| +1 | K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021 | — |
| +1 | K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K173408 | Mammomat RevelationSummary page 4…Product Code: MUE 4. Legally Marketed Predicate Device Trade Name: MAMMOMAT Revelation 510(k) #: K173408 Classification Name: Full Field Digital, System, X-Ray Mammographic Classification Panel: Radiology… | 2018 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Oct 24, 2025 | Class II | Z-0877-2026 | Component design/selection | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K233539 (Siemens Medical Solutions USA, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K173408.
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. 2020, 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 Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation.
With Biopsy Option:
The InSpect feature for MAMMOMAT Revelation 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193166 · printed Nov 3, 2026
Cite this page
510(k) Report. “K193166: MAMMOMAT Revelation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K193166
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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