510(k) · Cleared
Recalled · Class II · 2018Contrast Enhanced Digital Mammography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Jan 29, 2013 as substantially equivalent to K103485 (General Electric Company, 2011) after a 43-day review. Its family tree reaches back 2 generations to 2000. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 29, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to P990066 (2000). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000 · Recalled
- 1 generation backK103485 Senograph DS, Senograph EssenstialGeneral Electric Company · 2011
- This deviceK123873 Contrast Enhanced Digital MammographyHologic, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK233539 MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK254090 I-View®Hologic, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK253678 MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · cites it directly6descendants
- K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on4descendants
- K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024 · 3 generations on1descendant
- K254090I-View®Hologic, Inc. · 2026 · cites it directly0descendants
- K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P990066 | GE Healthcare Senographe Full Field Digital Mammography System | GE Healthcare | 2000 | 4 |
| −1 | K103485 | Senograph DS, Senograph Essenstial | General Electric Company | 2011 | — |
| 0 (this device) | K123873 | Contrast Enhanced Digital Mammography | Hologic, Inc. | 2013 | — |
| +1 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| +2 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +3 | K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +1 | K254090 | I-View® | Hologic, Inc. | 2026 | — |
| +4 | K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K103485 | Senograph DS, Senograph EssenstialSummary page 1…Telephone Number- 781-999-7558 Fax Number: 866- 652-8674 Date Prepared: December 14,2012 Predicate Devices: K103485 GE Healthcare Contrast Enhanced Spectral Mammography Device Description: The Contrast Enhanced Digital Mammography (CEDM… | 2011 |
What descends from it? (8)
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 |
|---|---|---|---|---|
| Dec 6, 2018 | Class II | Z-0685-2019 | Software design | Calibration issue not possible to visualize contrast uptake in the subtracted mammography images |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K173408 (Siemens Medi Cal Solutions, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K103485.
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?
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing
indication for diagnostic mammography with the Selenia Dimensions system. The CEDM
application shall enable contrast enhanced breast imaging using a dual energy technique.
This imaging technique can be used as an adjunct following mammography and/or
ultrasound exams to localize a known or suspected lesion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123873: Contrast Enhanced Digital Mammography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123873
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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