510(k) · Cleared
Recalled · 2008Real Time Stereotix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · IZH System, X-Ray, Mammographic
Cleared on May 11, 1995 after a 423-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- May 11, 1995
- Review
- 423 days
- Class
- Class II
- Product code
- IZH
- Recalls
- 2
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK941191 Real Time StereotixGE Medical Systems · 1995
- Descendant · cites it directly · 18 of its ownK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- Descendant · 3 generations on · 13 of its ownK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- Descendant · 4 generations on · 9 of its ownK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- Descendant · 5 generations on · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K040125Senographic StereoGe Medical Systems, Inc. · 2004 · cites it directly18descendants
- K071542Digital Stereoloc IILorad, A Hologic Co. · 2007 · 2 generations on14descendants
- K103512Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011 · 3 generations on13descendants
- K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013 · 4 generations on9descendants
- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | — |
| +1 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| +2 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| +3 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| +4 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| +5 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 202 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 |
|---|---|---|---|---|
| Jul 1, 2008 | Not classified | Z-2147-2008 | Radiation Control for Health and Safety Act | GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your… |
| Jul 1, 2008 | Not classified | Z-2146-2008 | Radiation Control for Health and Safety Act | GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040125 (Ge Medical Systems, Inc., 2004) has gone furthest, with 18 descendants of its own.
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 | — |
https://510kreport.com/device/K941191 · printed Nov 4, 2026
Cite this page
510(k) Report. “K941191: Real Time Stereotix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K941191
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026