510(k) · Cleared
ClearedLorad Digital Spot Mammography 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 23, 2004 as substantially equivalent to K921962 (Lorad Medical Systems, Inc., 1992) and 1 other predicate after an 18-day review. Its family tree reaches back 1 generation to 1992. 15 later devices descend from it.
- Decided
- Apr 23, 2004
- Review
- 18 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921962 (1992). 2 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK921962 Lorad Digital Spot MammographyLorad Medical Systems, Inc. · 1992
- This deviceK040884 Lorad Digital Spot Mammography SystemHologic, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- Descendant · 2 generations on · 13 of its ownK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- Descendant · 3 generations on · 9 of its ownK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- Descendant · 4 generations on · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 5 generations on · 4 of its ownK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K071542Digital Stereoloc IILorad, A Hologic Co. · 2007 · cites it directly14descendants
- K103512Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011 · 2 generations on13descendants
- K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013 · 3 generations on9descendants
- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · 4 generations on6descendants
- K193166MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921962 | Lorad Digital Spot Mammography | Lorad Medical Systems, Inc. | 1992 | — |
| 0 (this device) | K040884 | Lorad Digital Spot Mammography System | Hologic, Inc. | 2004 | — |
| +1 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| +2 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| +3 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| +4 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| +5 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K921962 | Lorad Digital Spot MammographySummary page 1…st Date Prepared: April 1, 2004 Common Name: DSM Proprietary Name: Digital Spot Mammography System Predicate Devices: Lorad DSM K921962A & K030666 Intended Use: DSM as part of a standard x-ray mammography unit is part of a ste… | 1992 |
| * | K030666 | Multicare Platinum System and AccessoriesSummary page 1…epared: April 1, 2004 Common Name: DSM Proprietary Name: Digital Spot Mammography System Predicate Devices: Lorad DSM K921962A & K030666 Intended Use: DSM as part of a standard x-ray mammography unit is part of a stereotactic l… | 2003 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071542 | Digital Stereoloc II | 2007 | 14 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K071542 (Lorad, A Hologic Co., 2007) has gone furthest, with 14 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.
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?
DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion
localization system that has the application of localizing, and then giving a physician the
capability of performing fine needle aspiration or core biopsy of lesions determined to be
suspicious through prior mammographic examination
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040884: Lorad Digital Spot Mammography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040884
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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