510(k) · Cleared
ClearedMulticare Platinum System and Accessories
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 Mar 25, 2003 after a 22-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- Mar 25, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK030666 Multicare Platinum System and AccessoriesLorad, A Hologic Co. · 2003
- Descendant · cites it directly · 15 of its ownK040884 Lorad Digital Spot Mammography SystemHologic, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- Descendant · 3 generations on · 13 of its ownK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- Descendant · 4 generations on · 9 of its ownK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- Descendant · 5 generations on · 6 of its ownK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K040884Lorad Digital Spot Mammography SystemHologic, Inc. · 2004 · cites it directly15descendants
- K071542Digital Stereoloc IILorad, A Hologic Co. · 2007 · 2 generations on14descendants
- K103512Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011 · 3 generations on13descendants
- K122836Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013 · 4 generations on9descendants
- K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030666 | Multicare Platinum System and Accessories | Lorad, A Hologic Co. | 2003 | — |
| +1 | K040884 | Lorad Digital Spot Mammography System | Hologic, Inc. | 2004 | — |
| +2 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| +3 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| +4 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| +5 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040884 (Hologic, Inc., 2004) has gone furthest, with 15 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?
The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system to produce a device that has specific application in first localizing, and then giving a physician the capacity 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/K030666 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030666: Multicare Platinum System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030666
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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