510(k) · Cleared
ClearedSiremobil Iso-C 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG · IZL System, X-Ray, Mobile
Cleared on Sep 10, 2003 as substantially equivalent to K003266 (Siemens Medical Solutions USA, Inc., 2000) and 2 other predicates after a 48-day review. Its family tree reaches back 1 generation to 2000. 2 of the 87 devices in its family, counting itself, have a Class I recall. 83 later devices descend from it.
- Decided
- Sep 10, 2003
- Review
- 48 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K003266 (2000). 3 ancestors in all. 83 later devices descend from it, 3 citing it directly. 2 of the 87 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- This deviceK032280 Siremobil Iso-C 3DSiemens AG · 2003
- Descendant · cites it directly · 52 of its ownK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- Descendant · 2 generations on · 51 of its ownK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- Descendant · cites it directly · 33 of its ownK081672 C-InsightMazor Surgical Technologies, Ltd. · 2008
- Descendant · 2 generations on · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- Descendant · cites it directly · 29 of its ownK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 83 · See all- K050996O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · cites it directly52descendants
- K060344O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · 2 generations on51descendants
- K081672C-InsightMazor Surgical Technologies, Ltd. · 2008 · cites it directly33descendants
- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · 2 generations on31descendants
- K061310Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · cites it directly29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| 0 (this device) | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| +1 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| +2 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| +1 | K081672 | C-Insight | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +2 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| +1 | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 1 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 11 | 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.
2 devices in this family have a Class I recall. 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
What descends from it? (83)
See all 833 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The Siremobil Iso-C 3D with extended Indications for Use is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C 3D. The extended Indications for Use to include the entire spine for the Siremobil Iso-C 3D contains no new hardware or software
The Siremobil Iso-C 3D is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures (e.g. bones and joints). The Siremobil Iso-C 3D is designed as a 3D imaging device for conditions such as complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the entire spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032280: Siremobil Iso-C 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032280
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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