510(k) · Cleared
Recalled · Class II · 2025Senographe Pristina
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
Cleared on Nov 3, 2016 as substantially equivalent to K990066 (Camtronics, Ltd., 1999) after an 83-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 3, 2016
- Review
- 83 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953974 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953974 Camvision 1000Medivision Medical Imaging, Ltd. · 1996
- 1 generation backK990066 CCD Camera, Model 9000Camtronics, Ltd. · 1999 · Recalled
- This deviceK162268 Senographe PristinaGE Healthcare · 2016
- Descendant · cites it directly · 1 of its ownK211725 Senographe PristinaGE Healthcare · 2021
- Descendant · 2 generations on · 0 of its ownK260087 Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena…GE Medical Systems SCS · 2026
- Descendant · cites it directly · 0 of its ownK163302 Senographe PristinaGE Healthcare · 2017
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 |
|---|---|---|---|---|---|
| −2 | K953974 | Camvision 1000 | Medivision Medical Imaging, Ltd. | 1996 | — |
| −1 | K990066 | CCD Camera, Model 9000 | Camtronics, Ltd. | 1999 | 2 |
| 0 (this device) | K162268 | Senographe Pristina | GE Healthcare | 2016 | — |
| +1 | K211725 | Senographe Pristina | GE Healthcare | 2021 | — |
| +2 | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | 2026 | — |
| +1 | K163302 | Senographe Pristina | GE Healthcare | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K990066 | CCD Camera, Model 9000Summary page 4…eld digital mammography system Class II CFR 892.1715 Product Code: MUE Predicate Device(s): Senographe Essential (P990066/S021) Device Description: Senographe Pristina is a new Full Field Digital Mammography (FFDM)… | 1999 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2025 | Class II | Z-0875-2026 | Radiation Control for Health and Safety Act | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j). |
| Dec 26, 2023 | Class II | Z-0862-2024 | Radiation Control for Health and Safety Act | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. |
| May 16, 2019 | Class II | Z-2131-2019 | Equipment maintenance | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K211725 (GE Healthcare, 2021) has gone furthest, with 1 descendant 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. 2016, 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?
Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional mammographic screen-film systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162268: Senographe Pristina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162268
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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