PMA · Approved
Recalled · 2011GE Healthcare Senographe Full Field Digital Mammography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MUE Full Field Digital, System, X-Ray, Mammographic
Approved on Jan 28, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 91-day review. 23 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 28, 2000
- Review
- 91 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 4
23 later devices descend from it, 6 citing it directly.
- This deviceP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000
- Descendant · cites it directly · 11 of its ownK103485 Senograph DS, Senograph EssenstialGeneral Electric Company · 2011
- Descendant · 2 generations on · 8 of its ownK123873 Contrast Enhanced Digital MammographyHologic, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 4 of its ownK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · cites it directly · 3 of its ownK110798 Senographe DS, Senographe EssentialGeneral Electric Company · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K103485Senograph DS, Senograph EssenstialGeneral Electric Company · 2011 · cites it directly11descendants
- K123873Contrast Enhanced Digital MammographyHologic, Inc. · 2013 · 2 generations on8descendants
- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · 3 generations on6descendants
- K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on4descendants
- K110798Senographe DS, Senographe EssentialGeneral Electric Company · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P990066 | GE Healthcare Senographe Full Field Digital Mammography System | GE Healthcare | 2000 | — |
| +1 | K103485 | Senograph DS, Senograph Essenstial | General Electric Company | 2011 | — |
| +2 | K123873 | Contrast Enhanced Digital Mammography | Hologic, Inc. | 2013 | 1 |
| +3 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| +4 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +1 | K110798 | Senographe DS, Senographe Essential | General Electric Company | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (23)
See all 236 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 17, 2011 | Not classified | Z-1063-2012 | Device Design | GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
| Sep 22, 2011 | Not classified | Z-0115-2012 | Software design | GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
| Sep 22, 2011 | Not classified | Z-0114-2012 | Software design | GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
| Feb 6, 2004 | Not classified | Z-0282-04 | Other | The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103485 (General Electric Company, 2011) has gone furthest, with 11 descendants of its own.
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.
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 | — |
https://510kreport.com/device/P990066 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990066: GE Healthcare Senographe Full Field Digital Mammography System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990066
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026