510(k) · Cleared
ClearedSample Imaging for Senographe 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 Jul 29, 2019 as substantially equivalent to K173408 (Siemens Medi Cal Solutions, Inc., 2018) after a 122-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jul 29, 2019
- Review
- 122 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941191 (1995). 14 ancestors in all, the oldest K921962 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- 5 generations backK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- 4 generations backK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- 3 generations backK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- 2 generations backK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- 1 generation backK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- This deviceK190809 Sample Imaging for Senographe PristinaGE Healthcare · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| −5 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| −4 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| −3 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| −2 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| −1 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| 0 (this device) | K190809 | Sample Imaging for Senographe Pristina | GE Healthcare | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K173408 | Mammomat RevelationSummary page 5…mammography platform. Classification Names: 21 CFR 892.1715, Class II Product Code: MUE Predicate Device: MAMMOMAT Revelation with InSpect feature (K173408) Reference devices: Pristina Serena (K173576) Device Description: Sample Imaging for Senographe Pristina is an additio… | 2018 |
| † | K173576 | Pristina Serena | 2018 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K173408.
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. 2019, 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?
Sample Imaging for Senographe PristinaTM with Pristina SerenaTM biopsy option is intended to provide digital X-ray images of the biopsy excised breast tissues while the patient is still under compression, to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190809: Sample Imaging for Senographe Pristina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190809
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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