510(k) · Cleared
Recalled · 2004Philips BV-29 Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Feb 20, 1991 after a 41-day review. The FDA summary names no predicate by number. 24 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 20, 1991
- Review
- 41 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 3
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK910115 Philips BV-29 Imaging SystemPhilips Medical Systems, Inc. · 1991
- Descendant · cites it directly · 23 of its ownK963093 Siremobil CompactSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 21 of its ownK040066 Siremobile C06Siemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 20 of its ownK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 4 generations on · 19 of its ownK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 15 of its ownK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K963093Siremobil CompactSiemens Medical Solutions USA, Inc. · 1996 · cites it directly23descendants
- K040066Siremobile C06Siemens Medical Solutions USA, Inc. · 2004 · 2 generations on21descendants
- K051133Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on20descendants
- K132094Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · 4 generations on19descendants
- K153244Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910115 | Philips BV-29 Imaging System | Philips Medical Systems, Inc. | 1991 | — |
| +1 | K963093 | Siremobil Compact | Siemens Medical Solutions USA, Inc. | 1996 | 2 |
| +2 | K040066 | Siremobile C06 | Siemens Medical Solutions USA, Inc. | 2004 | 2 |
| +3 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +4 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| +3 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963093 | Siremobil Compact | 1996 | 23 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2004 | Not classified | Z-1456-04 | Other | Potential for c-arm to move due to loose screws |
| Jul 20, 2004 | Not classified | Z-1453-04 | Other | Potential for c-arm to move due to loose screws |
| Jul 20, 2004 | Not classified | Z-1457-04 | Other | Potential for c-arm to move due to loose screws |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K963093 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 23 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/K910115 · printed Nov 5, 2026
Cite this page
510(k) Report. “K910115: Philips BV-29 Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K910115
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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