510(k) · Cleared
Recalled · Class II · 2026Philips Multidiagnost Eleva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · IZI System, X-Ray, Angiographic
Cleared on Oct 30, 2002 as substantially equivalent to K961374 (Philips Medical Systems, Inc., 1996) after a 15-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled 15 times.
- Decided
- Oct 30, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 15
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961374 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK961374 Philips Multidiagnost 4Philips Medical Systems, Inc. · 1996 · Recalled
- This deviceK023441 Philips Multidiagnost ElevaPhilips Medical Systems · 2002
- Descendant · cites it directly · 0 of its ownK050151 Multidiagnost ElevaPhilips Medical Systems North America, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K050151Multidiagnost ElevaPhilips Medical Systems North America, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961374 | Philips Multidiagnost 4 | Philips Medical Systems, Inc. | 1996 | 3 |
| 0 (this device) | K023441 | Philips Multidiagnost Eleva | Philips Medical Systems | 2002 | — |
| +1 | K050151 | Multidiagnost Eleva | Philips Medical Systems North America, Inc. | 2005 | 21 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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 |
|---|---|---|---|
| * | K961374 | Philips Multidiagnost 4Summary page 1…o the Philips MultiDiagnost 4 manufactured by Philips Medical Systems. The Philips MultiDiagnost 4 system received a 51O(k) substantially equivalent determination in K961374 on August 19, 1996. Device description: The Philips MultiDiagnost Eleva is a multi-functional, tilting C-arm system consist… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050151 | Multidiagnost Eleva | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2026 | Class II | Z-2411-2026 | Radiation Control for Health and Safety Act | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection |
| Jul 19, 2023 | Class II | Z-2404-2023 | Radiation Control for Health and Safety Act | A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation |
| Dec 30, 2019 | Class II | Z-1489-2020 | 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-1052-2019 | 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. |
| Mar 26, 2018 | Class II | Z-1605-2018 | Nonconforming Material/Component | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user. |
| Jul 19, 2016 | Class II | Z-2307-2016 | Device Design | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag |
| Jul 19, 2016 | Class II | Z-2305-2016 | Device Design | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag |
| Oct 14, 2013 | Class II | Z-1044-2015 | Radiation Control for Health and Safety Act | The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected. |
| May 21, 2012 | Class II | Z-1829-2012 | Device Design | MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement |
| Feb 24, 2012 | Not classified | Z-1196-2012 | Software design | Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values. |
| Feb 24, 2012 | Not classified | Z-1197-2012 | Software design | Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values. |
| Jan 9, 2012 | Not classified | Z-0985-2012 | Employee error | Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low |
| Oct 7, 2010 | Not classified | Z-1656-2011 | 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-0917-2011 | 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… |
| Jul 23, 2007 | Not classified | Z-0912-2007 | 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 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The MultiDiagnost Eleva is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023441: Philips Multidiagnost Eleva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023441
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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