510(k) · Cleared
ClearedOpdima
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IZH System, X-Ray, Mammographic
Cleared on Feb 2, 2001 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Feb 2, 2001
- Review
- 43 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK003945 OpdimaSiemens Medical Solutions USA, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK071015 Opdima Digital Mammographic X-Ray SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK072392 Opdima Digital Mammographic X-Ray SystemSiemens Medical Solutions USA, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003945 | Opdima | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +1 | K071015 | Opdima Digital Mammographic X-Ray System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K072392 | Opdima Digital Mammographic X-Ray System | Siemens Medical Solutions USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 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, K071015 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K003945 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003945: Opdima.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003945
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026