510(k) · Cleared
ClearedAffirm Prone Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · IZH System, X-Ray, Mammographic
Cleared on Apr 1, 2016 as substantially equivalent to K030666 (Lorad, A Hologic Co., 2003) and 1 other predicate after a 119-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Apr 1, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- 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 deviceK153486 Affirm Prone Biopsy SystemHologic, Inc. · 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) | K153486 | Affirm Prone Biopsy System | Hologic, Inc. | 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 |
|---|---|---|---|
| * | K030666 | Multicare Platinum System and AccessoriesSummary page 4…stem Regulation number: 21 CFR 892.1710 Product Code: IZH Class: II 3. Predicate Device: Multicare Platinum Prone Breast Biopsy Table (K030666) Affirm Breast Biopsy Guidance System (K122836) 4. Device Description: The Affirm Prone Biopsy Table is a mam… | 2003 |
| * | K122836 | Affirm Breast Biopsy Guidance SystemSummary page 4…Product Code: IZH Class: II 3. Predicate Device: Multicare Platinum Prone Breast Biopsy Table (K030666) Affirm Breast Biopsy Guidance System (K122836) 4. Device Description: The Affirm Prone Biopsy Table is a mammographic x-ray system intended for lesion loc… | 2013 |
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 21 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K030666.
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 Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153486: Affirm Prone Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153486
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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