510(k) · Cleared
Recalled · Class II · 2019Phillips Omnidiagnost Eleva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jul 17, 2003 as substantially equivalent to K982993 (Philips Medical Systems, Inc., 1998) after a 15-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 17, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912470 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 1 generation backK982993 Philips OmnidiagnostPhilips Medical Systems, Inc. · 1998 · Recalled
- This deviceK032046 Phillips Omnidiagnost ElevaPhilips Medical Systems, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK092713 Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK050692 FLXISPhilips Medical Systems North America Co. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −1 | K982993 | Philips Omnidiagnost | Philips Medical Systems, Inc. | 1998 | 4 |
| 0 (this device) | K032046 | Phillips Omnidiagnost Eleva | Philips Medical Systems, Inc. | 2003 | — |
| +1 | K092713 | Spectre Wireless Encrypted Footswitch and Hand Switch System | Transamerican Medical Imaging | 2010 | 1 |
| +1 | K050692 | FLXIS | Philips Medical Systems North America Co. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982993 | Philips OmnidiagnostSummary page 1…ially equivalent to the Philips OmniDiagnost manufactured by Philips Medical Systems. The OmniDiagnost system received a 51O(k) substantially equivalent determination in K982993 on August 26, 1998. Device description: The Philips OmniDiagnost Eleva is a multifunctional, universal, overtable X-ray system o… | 1998 |
What descends from it? (2)
2 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 30, 2019 | Class II | Z-1490-2020 | Component design/selection | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible. |
| Feb 28, 2019 | Class II | Z-1056-2019 | Component design/selection | The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. |
| May 1, 2018 | Class II | Z-2300-2018 | Device Design | The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This… |
| Oct 7, 2010 | Not classified | Z-1657-2011 | Nonconforming Material/Component | A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown. |
| Mar 6, 2009 | Not classified | Z-0918-2011 | Other | Images from two different patients may be combined in one patient folder in the Digital Image (DI) or may be combined as one (printed) image. It is possible that an image of a previous patient registered in the DI will be overwritten with… |
| Dec 10, 2008 | Not classified | Z-0352-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Mar 22, 2008 | Not classified | Z-1374-2008 | Software design | Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off. |
| Jul 23, 2007 | Not classified | Z-0911-2007 | Other | Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 7.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K092713 (Transamerican Medical Imaging, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Philips OmniDiagnost Eleva is a diagnostic imaging device intended for
radiographic, fluoroscopic, angiographic, and interventional applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032046: Phillips Omnidiagnost Eleva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032046
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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