510(k) · Cleared
Recalled · 2005Siremobil Compact
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 Sep 3, 1996 as substantially equivalent to K913525 (Siemens Medical Solutions USA, Inc., 1991) and 3 other predicates after a 26-day review. Its family tree reaches back 1 generation to 1991. 23 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 3, 1996
- Review
- 26 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K910115 (1991). 4 ancestors in all. 23 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK910115 Philips BV-29 Imaging SystemPhilips Medical Systems, Inc. · 1991 · Recalled
- This deviceK963093 Siremobil CompactSiemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 21 of its ownK040066 Siremobile C06Siemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 20 of its ownK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 3 generations on · 19 of its ownK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 15 of its ownK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 10 of its ownK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K040066Siremobile C06Siemens Medical Solutions USA, Inc. · 2004 · cites it directly21descendants
- K051133Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on20descendants
- K132094Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · 3 generations on19descendants
- K153244Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on15descendants
- K181550Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910115 | Philips BV-29 Imaging System | Philips Medical Systems, Inc. | 1991 | 3 |
| 0 (this device) | K963093 | Siremobil Compact | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | K040066 | Siremobile C06 | Siemens Medical Solutions USA, Inc. | 2004 | 2 |
| +2 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +3 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| +2 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| +3 | K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K913525 | Mobile X-Ray SystemSummary page 3…substantially equivalent to the following medical devices currently in commercial distribution. Model Company FDA K-Number Siremobil 2000 Siemens Medical Systems, Inc. K913525 Stenoscop 6000/9000 General Electric, Inc. K910902 BV 29 Philips, Inc. K910115 Series 9600 OEC, Inc. K926056 Date Kathleen Ruth… | 1991 |
| * | K910902 | VMX Mobile X-Ray SystemSummary page 3…devices currently in commercial distribution. Model Company FDA K-Number Siremobil 2000 Siemens Medical Systems, Inc. K913525 Stenoscop 6000/9000 General Electric, Inc. K910902 BV 29 Philips, Inc. K910115 Series 9600 OEC, Inc. K926056 Date Kathleen Rutherford Manager, Regulatory Submissions === Page 4… | 1991 |
| * | K910115 | Philips BV-29 Imaging SystemSummary page 3…ial distribution. Model Company FDA K-Number Siremobil 2000 Siemens Medical Systems, Inc. K913525 Stenoscop 6000/9000 General Electric, Inc. K910902 BV 29 Philips, Inc. K910115 Series 9600 OEC, Inc. K926056 Date Kathleen Rutherford Manager, Regulatory Submissions RVIC) ) SERVICEs, s 1 ;… | 1991 |
| * | K926056 | 9600 Fluoroscopic Imaging SystemSummary page 3…ny FDA K-Number Siremobil 2000 Siemens Medical Systems, Inc. K913525 Stenoscop 6000/9000 General Electric, Inc. K910902 BV 29 Philips, Inc. K910115 Series 9600 OEC, Inc. K926056 Date Kathleen Rutherford Manager, Regulatory Submissions RVIC) ) SERVICEs, s 1 ;“Q / DEPARTMENT OF HEALTH & HU… | 1993 |
What descends from it? (23)
See all 232 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-0120-06 | Other | Screws may become loose and fall into the OR field during surgery. |
| Aug 1, 2005 | Not classified | Z-0121-06 | 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?
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K040066 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 21 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 Compact 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 Compact can operate in four different modes, Digital Radiography, Fluoroscopy and pulsed Fluoroscopy and Cassette exposure 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/K963093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963093: Siremobil Compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963093
Report an extraction error
Are you the manufacturer?
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