510(k) · Cleared
Recalled · Class II · 2017Affirm Lateral Arm Upright Biopsy Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic · IZH System, X-Ray, Mammographic
Cleared on Aug 10, 2016 as substantially equivalent to K122836 (Lorad, A Hologic Co., 2013) and 1 other predicate after a 64-day review. Its family tree reaches back 5 generations to 1995. It has been recalled once.
- Decided
- Aug 10, 2016
- Review
- 64 days
- Class
- Class II
- Product code
- IZH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K941191 (1995). 8 ancestors in all, the oldest K921962 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- 4 generations backK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- 3 generations backK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- 2 generations backK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- 1 generation backK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- This deviceK161575 Affirm Lateral Arm Upright Biopsy AccessoryHologic · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| −4 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| −3 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| −2 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| −1 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| 0 (this device) | K161575 | Affirm Lateral Arm Upright Biopsy Accessory | Hologic | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K122836 | Affirm Breast Biopsy Guidance SystemSummary page 4…Marketed Predicate Device: Trade name: Affirm Breast Biopsy Guidance System General name: Mammographic X-ray system Submitter / 510(k) Holder: HOLOGIC, Inc. 510(k) #’s: K122836, cleared on 01/11/13 Product Code: IZH Regulation Number: 892.1710 Identification of the Legally Marketed Reference Device: Trad… | 2013 |
| * | K040125 | Senographic StereoSummary page 4…of the Legally Marketed Reference Device: Trade name: GE Senographe General name: Mammographic X-ray system Submitter / 510(k) Holder: General Electric, Inc. 510(k) #’s: K040125, cleared on 04/19/04 Product Code: IZH Regulation Number: 892.1710 Device Description: This submission introduces… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2017 | Class II | Z-0351-2018 | Component change control | The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K122836.
How does its category compare?
All IZH devicesIZH 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 · 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161575: Affirm Lateral Arm Upright Biopsy Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161575
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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