510(k) · Cleared
ClearedAffirm Contrast Biopsy
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 Oct 5, 2020 as substantially equivalent to K103512 (Hologic, Inc., 2011) after a 53-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Oct 5, 2020
- Review
- 53 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). No later device cites it as a predicate yet.
- 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 deviceK202294 Affirm Contrast BiopsyHologic, Inc. · 2020
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) | K202294 | Affirm Contrast Biopsy | Hologic, Inc. | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 5…Class II Review Panel: Radiology Submitter/510(k) Holder: Hologic, Inc. Clearance: K103512 (cleared January 07, 2011) Identification of the Legally Marketed Reference Device: Trade Name: Cont… | 2011 |
| † | K123873 | Contrast Enhanced Digital Mammography | 2013 |
| † | K161575 | Affirm Lateral Arm Upright Biopsy Accessory | 2016 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 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. 2020, 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?
Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).…
Read the full statement (167 words)
Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm® Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202294: Affirm Contrast Biopsy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202294
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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