510(k) · Cleared
Recalled · 2005Siremobil Iso-C 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Mar 9, 2004 after a 26-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 70 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 2004
- Review
- 26 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 1
- Predicates
- 1
70 later devices descend from it, 3 citing it directly.
- This deviceK040347 Siremobil Iso-C 3DSiemens Medical Systems, Inc. · 2004
- 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 · 3 generations on · 24 of its ownK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 4 generations on · 23 of its ownK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 5 generations on · 21 of its ownK140167 Renaissance X SystemMazor Robotics, Ltd. · 2014
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K081672C-InsightMazor Surgical Technologies, Ltd. · 2008 · cites it directly33descendants
- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · 2 generations on31descendants
- K110911Renaissance SystemMazor Robotics, Ltd. · 2011 · 3 generations on24descendants
- K113228Renaissance SystemMazor Robotics, Ltd. · 2011 · 4 generations on23descendants
- K140167Renaissance X SystemMazor Robotics, Ltd. · 2014 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040347 | Siremobil Iso-C 3D | Siemens Medical Systems, Inc. | 2004 | — |
| +1 | K081672 | C-Insight | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +2 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| +3 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +4 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +5 | K140167 | Renaissance X System | Mazor Robotics, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 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.
Planning a device in OXO? 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? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K032088 | FDA’s K032088 is Modification to Thermacool TC System Our OCR of the scanned summary read K032088, FDA’s number for Modification to Thermacool TC System (Thermage, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Siemens Siremobil Iso-C 3D”. Kept off the family tree. Summary page 1…rm device. The package is substantially equivalent to the following devices: Predicate Device Name FDA Clearance Number | FDA Clearance Date Siemens Siremobil Iso-C 3D K032088 09/10/03 Simplified 510(k) for Siemens Medical Solution Page § Siremobil Iso-C 3D 6. Device Description: ’ o oz… | 2003 |
What descends from it? (70)
See all 703 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2005 | Not classified | Z-0122-06 | Other | Screws may become loose and fall into the OR field during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081672 (Mazor Surgical Technologies, Ltd., 2008) has gone furthest, with 33 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 | — |
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 include the high contrast objects and anatomical structures of the entire body. The Siremobil Iso-C 3D contains no new hardware or software.
The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040347 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040347: Siremobil Iso-C 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040347
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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