510(k) · Cleared
ClearedSenographe DS, Senographe Essential
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Company · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Dec 22, 2011 as substantially equivalent to P990066 (GE Healthcare, 2000) after a 275-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Dec 22, 2011
- Review
- 275 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P990066 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000 · Recalled
- This deviceK110798 Senographe DS, Senographe EssentialGeneral Electric Company · 2011
- Descendant · cites it directly · 1 of its ownK220073 RMF-2000DRTECH Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK254092 Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK131885 Senographe Essential, Premium View I (Pvi)GE Medical Systems SCS · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P990066 | GE Healthcare Senographe Full Field Digital Mammography System | GE Healthcare | 2000 | 4 |
| 0 (this device) | K110798 | Senographe DS, Senographe Essential | General Electric Company | 2011 | — |
| +1 | K220073 | RMF-2000 | DRTECH Corporation | 2023 | — |
| +2 | K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | 2026 | — |
| +1 | K131885 | Senographe Essential, Premium View I (Pvi) | GE Medical Systems SCS | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | P990066 | GE Healthcare Senographe Full Field Digital Mammography SystemSummary page 1…l Field Digital Mammography System Classification Names: 21 CFR 892.1715, Class 11 Product Code: MUE Predicate Device(s): Senographe DS-P990066/S16, Senographe Essential-P990066/52 1 Device Description: The Senographe DS and Senogra… | 2000 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2011, 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 Senographe DS and Senographe Essential FFDM systems generate digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe DS and Senographe Essential FFDM systems are intended to be used in the same clinical applications as traditional film-based mammographic systems. Premium View is an image-processing algorithm, which increases the visibility of breast structures. The main advantage is to provide…
Read the full statement (199 words)
The Senographe DS and Senographe Essential FFDM systems generate digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe DS and Senographe Essential FFDM systems are intended to be used in the same clinical applications as traditional film-based mammographic systems.
Premium View is an image-processing algorithm, which increases the visibility of breast structures. The main advantage is to provide a single breast image, where the contrast in the fatty tissues is similar to that obtained by setting WW (window width) and WL (window level) for optimum visualization of fatty tissues, and the contrast in the fibro-glandular tissue is similar to that obtained by setting WW and WL for optimal visualization of fibro-glandular tissues.
PVi is an option that can simplify' the presentation of mammographic images, improve workflow, and streamline the review process of images with very dark or bright areas by presenting the image with the WW and WL optimized for review with minimal need for the user to make adjustments for the various tissue areas. This could be especially useful with patients who have very dense breasts, or implants that currently require multiple adjustments of WW and WL to review.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110798 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110798: Senographe DS, Senographe Essential.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110798
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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