510(k) · Cleared
ClearedDigital Stereoloc II
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 Jul 5, 2007 as substantially equivalent to K040884 (Hologic, Inc., 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1995. 14 later devices descend from it.
- Decided
- Jul 5, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K941191 (1995). 5 ancestors in all, the oldest K921962 (1992). 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- 1 generation backK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- This deviceK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- Descendant · cites it directly · 13 of its ownK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- Descendant · 2 generations on · 9 of its ownK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- Descendant · 3 generations on · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 4 of its ownK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 5 generations on · 1 of its ownK233539 MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K103512Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011 · cites it directly13descendants
- K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013 · 2 generations on9descendants
- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · 3 generations on6descendants
- K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on4descendants
- K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| −1 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| +1 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| +2 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| +3 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| +4 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +5 | K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K950220 | Hologic Lorad StereoLoc II Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…-surgical localization or treatment devices). Comparison With Predicate Devices: The Hologic Digital StereoLoc II is substantially equivalent to the following devices: K950220 Hologic Lorad StereoLoc II K040884 Hologic Lorad DSM K040 125 Senographe Stereo General Electric Medical Systems These devices a… | |
| * | K040884 | Lorad Digital Spot Mammography SystemSummary page 1…Fax Number: (203) 731-8440 Date Prepared: May 4, 2007 Predicate Devices: K952210 Hologic Lorad StereoLoc II K040884 Hologic Lorad DSM K040 125 Senographe Stereo General Electric Medical Systems Device Descrip… | 2004 |
| * | K040125 | Senographic StereoSummary page 1…: May 4, 2007 Predicate Devices: K952210 Hologic Lorad StereoLoc II K040884 Hologic Lorad DSM K040 125 Senographe Stereo General Electric Medical Systems Device Description: The Digital StereoLoc II is an optional ac… | 2004 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103512 | Affirm Breast Biopsy Guidance System | 2011 | 13 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K103512 (Hologic, Inc., 2011) has gone furthest, with 13 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. 2007, 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 Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071542: Digital Stereoloc II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071542
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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