510(k) · Cleared
Recalled · Class II · 2026Multidiagnost Eleva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · KPR System, X-Ray, Stationary
Cleared on Feb 9, 2005 as substantially equivalent to K023441 (Philips Medical Systems, 2002) after a 16-day review. Its family tree reaches back 2 generations to 1996. It has been recalled 21 times.
- Decided
- Feb 9, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961374 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K023441 | Philips Multidiagnost ElevaSummary page 1…Philips Medical Systems Nederland B.V. The MultiDiagnost Eleva with image intensifier and XTV imaging system received a 510(k) substantially equivalent determination in K023441 on October 30' , 2002. Device description: The MultiDiagnost Eleva (with a flat detector) is a multi-functional/universal, tilti… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 |
| Aug 22, 2024 | Class II | Z-3168-2024 | Device Design | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury. |
| Aug 15, 2023 | Class II | Z-2587-2023 | Device Design | A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible. |
| 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-1055-2019 | 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. |
| Feb 19, 2019 | Class II | Z-1140-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Feb 19, 2019 | Class II | Z-1141-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Mar 26, 2018 | Class II | Z-1606-2018 | 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. |
| Mar 26, 2018 | Class II | Z-1608-2018 | 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. |
| Mar 26, 2018 | Class II | Z-1607-2018 | 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. |
| Mar 26, 2018 | Class II | Z-1609-2018 | 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. |
| Mar 26, 2018 | Class II | Z-1603-2018 | 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. |
| Sep 24, 2014 | Class II | Z-1279-2016 | Device Design | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Sep 24, 2014 | Class II | Z-1280-2016 | Device Design | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Oct 14, 2013 | Class II | Z-1045-2015 | 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. |
| Jul 11, 2012 | Class II | Z-2156-2012 | Software design | When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. |
| May 21, 2012 | Class II | Z-1829-2012 | Device Design | MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement |
| Jan 9, 2012 | Not classified | Z-0936-2012 | Software design | The skin dose and skin dose rate values are calculated using an incorrect point of reference. Therefore, the AKR as displayed and stored in patient records is too low, although the dose as received by the patient is not affected. |
| Dec 30, 2008 | Not classified | Z-0623-2009 | Radiation Control for Health and Safety Act | System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur. |
| Nov 29, 2007 | Not classified | Z-1137-2008 | Software design | Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to… |
The 5 latest of 21 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 9 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
As a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: * Digestive System: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS). * Skeletal System: Bone studies. * Urinary…
Read the full statement (99 words)
As a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas:
* Digestive System:
Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS).
* Skeletal System:
Bone studies.
* Urinary System:
IVP, Cystograms, Percutaneous Nephrolithotomy, Nephrostomy tube placement.
* Reproductive System:
Hysterosalpingograms, Vena spermatica, Cavemography.
* Respiratory System:
Thorax, Bronchoscopy, Pulmonary biopsies.
* Circulatory System:
Venography, Arteriography, Thrombolytic Therapy, Embolizations, Embolectomy, TVC filter placement, Dilatations, Stent placement.
* Various:
Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050151: 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/K050151
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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