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 Medical Solutions USA, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Dec 1, 2000 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 441 devices in its family, counting itself, have a Class I recall. 440 later devices descend from it.
- Decided
- Dec 1, 2000
- Review
- 44 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 0
440 later devices descend from it, 7 citing it directly. 2 of the 441 devices in this family, counting this one, have a Class I recall.
- This deviceK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- Descendant · cites it directly · 244 of its ownK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- Descendant · 2 generations on · 218 of its ownK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- Descendant · 3 generations on · 210 of its ownK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- Descendant · 3 generations on · 172 of its ownK062673 Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006
- Descendant · 3 generations on · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
Showing 5 of 440 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 440 · See all- K011447IN Space 3DSiemens Medical Solutions USA, Inc. · 2001 · cites it directly244descendants
- K043469Syngo Inspace 4DSiemens AG Medical Solutions · 2005 · 2 generations on218descendants
- K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007 · 3 generations on210descendants
- K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006 · 3 generations on172descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · 3 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| +1 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +2 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| +3 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| +3 | K062673 | Modification to Syngo Inspace 4D | Siemens AG Medical Solutions | 2006 | — |
| +3 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 14 | 0 |
| 2012 | 15 | 0 |
| 2013 | 16 | 0 |
| 2014 | 13 | 0 |
| 2015 | 20 | 0 |
| 2016 | 19 | 0 |
| 2017 | 16 | 0 |
| 2018 | 32 | 0 |
| 2019 | 17 | 0 |
| 2020 | 33 | 0 |
| 2021 | 25 | 1 |
| 2022 | 28 | 0 |
| 2023 | 32 | 0 |
| 2024 | 33 | 0 |
| 2025 | 47 | 1 |
| 2026 | 38 | 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.
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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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? (440)
See all 4407 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011447 | IN Space 3D | 2001 | 244 |
| K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | 2003 | 88 |
| K032280 | Siremobil Iso-C 3D | 2003 | 83 |
| K050996 | O-Arm Imaging System | 2005 | 52 |
| K081672 | C-Insight | 2008 | 33 |
| K061310 | Ziehm Vario 3D Digital Mobile Imaging System | 2006 | 29 |
| K022337 | 3D Navigation Interface for Siremobile Iso-C 3D | 2002 | 22 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K011447 (Siemens Medical Solutions USA, Inc., 2001) has gone furthest, with 244 descendants of its own.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K003266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003266: Siremobil Iso-C 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003266
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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