510(k) · Cleared
Recalled · 2009Multistar D Angiographic X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IZI System, X-Ray, Angiographic
Cleared on Sep 7, 1993 after a 211-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 7 times.
- Decided
- Sep 7, 1993
- Review
- 211 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 7
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2009 | Not classified | Z-0167-2010 | Labeling False and Misleading | The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall. |
| May 1, 2009 | Not classified | Z-1437-2009 | Other | Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall. |
| Aug 11, 2008 | Not classified | Z-0135-2009 | Software design | Unintended movement of the system table and/or C arm. |
| Aug 11, 2008 | Not classified | Z-0139-2009 | Software design | Unintended movement of the system table and/or C arm. |
| Aug 11, 2008 | Not classified | Z-0142-2009 | Software design | Unintended movement of the system table and/or C arm. |
| Aug 11, 2008 | Not classified | Z-0147-2009 | Software design | Unintended movement of the system table and/or C arm. |
| Aug 11, 2008 | Not classified | Z-0148-2009 | Software design | Unintended movement of the system table and/or C arm. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K930635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K930635: Multistar D Angiographic X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930635
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026