510(k) · Cleared
ClearedSenographic Stereo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · IZH System, X-Ray, Mammographic
Cleared on Apr 19, 2004 as substantially equivalent to K941191 (GE Medical Systems, 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 18 later devices descend from it.
- Decided
- Apr 19, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941191 (1995). 18 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- This deviceK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- Descendant · 2 generations on · 13 of its ownK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- Descendant · 3 generations on · 9 of its ownK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- Descendant · 4 generations on · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 5 generations on · 4 of its ownK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K071542Digital Stereoloc IILorad, A Hologic Co. · 2007 · cites it directly14descendants
- K103512Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011 · 2 generations on13descendants
- K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013 · 3 generations on9descendants
- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · 4 generations on6descendants
- K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| 0 (this device) | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| +1 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| +2 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| +3 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| +4 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| +5 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2024 | 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 IZH? 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 IZH device
- #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K941191 | Real Time StereotixSummary page 1…ent to the device listed below: Model: SenoVision Manufacturer: General Electric Medical Systems 510 (k): K941191 4. Device Description: SCIENTIFIC CONCEPT USED If an image of the same object is taken with the tube arm at… | 1995 |
What descends from it? (18)
See all 183 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 IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · IZH
64in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZH
15in 2025
MAUDE reports naming product code IZH, 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 | 3 | 30 | 0 | 11 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 3 | 64 | 0 | 9 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040125 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040125: Senographic Stereo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040125
Report an extraction error
Are you the manufacturer?
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