510(k) · Cleared
Recalled · 2005Siremobile C06
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 Feb 12, 2004 as substantially equivalent to K963093 (Siemens Medical Solutions USA, Inc., 1996) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1991. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 12, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910115 (1991). 6 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK910115 Philips BV-29 Imaging SystemPhilips Medical Systems, Inc. · 1991 · Recalled
- 1 generation backK963093 Siremobil CompactSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- This deviceK040066 Siremobile C06Siemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 20 of its ownK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 2 generations on · 19 of its ownK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- Descendant · cites it directly · 15 of its ownK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 10 of its ownK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 10 of its ownK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K051133Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005 · cites it directly20descendants
- K132094Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · 2 generations on19descendants
- K153244Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · cites it directly15descendants
- K181550Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on10descendants
- K181560Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910115 | Philips BV-29 Imaging System | Philips Medical Systems, Inc. | 1991 | 3 |
| −1 | K963093 | Siremobil Compact | Siemens Medical Solutions USA, Inc. | 1996 | 2 |
| 0 (this device) | K040066 | Siremobile C06 | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +2 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| +1 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| +2 | K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
| +2 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963093 | Siremobil CompactSummary page 1…iremobil C 06 is substantially equivalent 10 the following devices: Predicate Device Name ___510(k) Number Clearance Datc Comparable Properties Sicmens Siremobil Compact K963093 08/07/1996 e Hardware e Control Sofiware N e |ntended usc Siemens Siremobil 1so-C K973598 11/10/1997 e [lardware e Control Sofiwa… | 1996 |
| * | K973598 | Siremobil CO2Summary page 1…___510(k) Number Clearance Datc Comparable Properties Sicmens Siremobil Compact K963093 08/07/1996 e Hardware e Control Sofiware N e |ntended usc Siemens Siremobil 1so-C K973598 11/10/1997 e [lardware e Control Sofiware i e |ntended usc Sicmens Medical Solutions, Inc. USA - Paye 161 Special 510(k) Siremab… | 1997 |
What descends from it? (21)
See all 213 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 |
|---|---|---|---|---|
| Dec 12, 2005 | Not classified | Z-0439-06 | Other | patient information can be stored in another patient's file. |
| Aug 1, 2005 | Not classified | Z-0119-06 | 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K051133 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K963093.
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 C06 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil C06 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
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/K040066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040066: Siremobile C06.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040066
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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