510(k) · Cleared
ClearedAffirm Breast Biopsy Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lorad, A Hologic Co. · IZH System, X-Ray, Mammographic
Cleared on Jan 11, 2013 as substantially equivalent to K103512 (Hologic, Inc., 2011) after a 116-day review. Its family tree reaches back 4 generations to 1995. 9 later devices descend from it.
- Decided
- Jan 11, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941191 (1995). 7 ancestors in all, the oldest K921962 (1992). 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- 3 generations backK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- 2 generations backK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- 1 generation backK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- This deviceK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- Descendant · cites it directly · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK233539 MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK253678 MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK210955 Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · cites it directly6descendants
- K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on4descendants
- K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024 · 3 generations on1descendant
- K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc. · 2026 · 4 generations on0descendants
- K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| −3 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| −2 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| −1 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| 0 (this device) | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| +1 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| +2 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +3 | K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +4 | K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | 2026 | — |
| +3 | K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K103512 | Affirm Breast Biopsy Guidance SystemSummary page 1…731-8337 Fax Number: (203) 731-8440 Date Prepared: August 14, 2012 Predicate Device: Affirm Breast Biopsy Guidance System, K103512 Device Description: The Affirm Breast Biopsy Guidance System is used with Selenia Dimensions 2D or with Selenia Dimensions 3D t… | 2011 |
What descends from it? (9)
3 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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K173408 (Siemens Medi Cal Solutions, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K103512.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
The Affirm breast biopsy guidance system is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in the breast in three dimensions. 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/K122836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122836: Affirm Breast Biopsy Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122836
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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