510(k) · Cleared
ClearedSenographe Essential, Premium View I (Pvi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Sep 26, 2013 as substantially equivalent to P990066 (GE Healthcare, 2000) and 1 other predicate after a 93-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Sep 26, 2013
- Review
- 93 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P990066 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000 · Recalled
- 1 generation backK110798 Senographe DS, Senographe EssentialGeneral Electric Company · 2011
- This deviceK131885 Senographe Essential, Premium View I (Pvi)GE Medical Systems SCS · 2013
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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…Digital Mammography System Classification Names: 21 CFR 892.1715, Class 11 Product Code: MUE Predicate Devicels): Senographe Essential -P990066/S 21 with Premium View K110798 5-2 === Page 2 ==… | 2000 |
| * | K110798 | Senographe DS, Senographe EssentialSummary page 1…FR 892.1715, Class 11 Product Code: MUE Predicate Devicels): Senographe Essential -P990066/S 21 with Premium View K110798 5-2 GE Healthcare 510(k) Premoarket Notification Submission… | 2011 |
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 13 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 5 other devices also cite its predicate P990066.
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?
The Senographe Essential FFDM systems generate digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The 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…
Read the full statement (225 words)
The Senographe Essential FFDM systems generate digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The 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 thin breasts, very dense breasts. or implants that currently require multiple adjustments of WW and WL to review.
eContrast accommodates different customer display preferences in screening and diagnosis, with 5 different levels, while keeping the PVi option for implants. eContrast postprocessing is also available for stereo images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131885 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131885: Senographe Essential, Premium View I (Pvi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131885
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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