510(k) · Cleared
ClearedSenographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
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 Mar 24, 2026 as substantially equivalent to K211725 (GE Healthcare, 2021) after a 71-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Mar 24, 2026
- Review
- 71 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953974 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK953974 Camvision 1000Medivision Medical Imaging, Ltd. · 1996
- 3 generations backK990066 CCD Camera, Model 9000Camtronics, Ltd. · 1999 · Recalled
- 2 generations backK162268 Senographe PristinaGE Healthcare · 2016 · Recalled
- 1 generation backK211725 Senographe PristinaGE Healthcare · 2021
- This deviceK260087 Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena…GE Medical Systems SCS · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953974 | Camvision 1000 | Medivision Medical Imaging, Ltd. | 1996 | — |
| −3 | K990066 | CCD Camera, Model 9000 | Camtronics, Ltd. | 1999 | 2 |
| −2 | K162268 | Senographe Pristina | GE Healthcare | 2016 | 3 |
| −1 | K211725 | Senographe Pristina | GE Healthcare | 2021 | — |
| 0 (this device) | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | 2026 | — |
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 |
|---|---|---|---|
| * | K211725 | Senographe PristinaSummary page 5…CFR 892.1715 Regulation Name Full-Field Digital Mammography System Predicate Device Senographe Pristina cleared under 510(k) number K211725 Regulation Name: Full-Field Digital Mammography System: 21CFR 892.1715… | 2021 |
| † | K173576 | Pristina Serena | 2018 |
| † | K211215 | SenoBright HD | 2021 |
| † | K193334 | Pristina Serena Bright | 2020 |
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 30 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2026, 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 Pristina system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer. SenoBright HD is an extension of the existing indication for diagnostic mammography with Senographe Pristina. The SenoBright application shall enable contrast enhanced breast imaging using a dual energy technique.…
Read the full statement (236 words)
The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.
SenoBright HD is an extension of the existing indication for diagnostic mammography with Senographe Pristina. The SenoBright application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and ultrasound exams to help localize a known or suspected lesion
The Pristina Serena option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).
The Pristina Serena Bright option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM) under the same breast compression. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA). CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260087: Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260087
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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