510(k) · Cleared
Recalled · Class II · 2023Philips Easydiagnost Eleva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · KPR System, X-Ray, Stationary
Cleared on Jun 17, 2003 as substantially equivalent to K970640 (Philips Medical Systems North America, Inc., 1997) after a 32-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it. It has been recalled 15 times.
- Decided
- Jun 17, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 15
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924593 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924593 Diagnost 76 Family*R/F Systems - Release 4.4Philips Medical Systems, Inc. · 1992 · Recalled
- 1 generation backK970640 Philips Easy DiagnostPhilips Medical Systems North America, Inc. · 1997 · Recalled
- This deviceK031535 Philips Easydiagnost ElevaPhilips Medical Systems North America Co. · 2003
- Descendant · cites it directly · 2 of its ownK173433 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK163210 Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK212837 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK203087 CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK233945 ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH · 2024 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173433ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018 · cites it directly2descendants
- K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017 · cites it directly2descendants
- K212837ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2021 · 2 generations on1descendant
- K203087CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2020 · 2 generations on1descendant
- K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924593 | Diagnost 76 Family*R/F Systems - Release 4.4 | Philips Medical Systems, Inc. | 1992 | 1 |
| −1 | K970640 | Philips Easy Diagnost | Philips Medical Systems North America, Inc. | 1997 | 5 |
| 0 (this device) | K031535 | Philips Easydiagnost Eleva | Philips Medical Systems North America Co. | 2003 | — |
| +1 | K173433 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2018 | 7 |
| +1 | K163210 | Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2017 | 8 |
| +2 | K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021 | 5 |
| +2 | K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2020 | 6 |
| +3 | K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | 2024 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K970640 | Philips Easy DiagnostSummary page 2…ally equivalent to, the Philips EasyDIAGNOST manufactured by Philips Medical Systems. The EasyDIAGNOST received 5 10(k) clearance March 2 1, 1997 ( see 5 10(k) K970640). The Eleva control concept was cleared by the FDA for the Philips MultiDiagnost Eleva (see 510(k) K023441). The intend… | 1997 |
What descends from it? (6)
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 |
|---|---|---|---|---|
| Sep 21, 2023 | Class II | Z-0279-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| Jun 2, 2020 | Class II | Z-2523-2020 | Process control | Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction. |
| Jul 14, 2017 | Class II | Z-0311-2018 | Under Investigation by firm | If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is… |
| Aug 19, 2014 | Class II | Z-0365-2016 | Device Design | The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient. |
| Oct 30, 2013 | Class II | Z-0431-2014 | Software design | The delivered application software was an outdated version to the model of equipment. |
| Jan 16, 2013 | Class II | Z-0767-2013 | Software design (manufacturing process) | The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. |
| Jul 11, 2012 | Class II | Z-2208-2012 | Equipment maintenance | Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors. |
| May 11, 2012 | Class II | Z-1821-2012 | Device Design | If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to… |
| Mar 9, 2012 | Not classified | Z-1283-2012 | Software design | Underexposed image due to lag in switching between auxiliaries |
| Feb 14, 2012 | Not classified | Z-1216-2012 | Software design | Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system |
| Mar 6, 2009 | Not classified | Z-0916-2011 | 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… |
| Jan 21, 2009 | Not classified | Z-0479-2011 | Software design | Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect… |
| Dec 10, 2008 | Not classified | Z-0353-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Jul 9, 2008 | Not classified | Z-2194-2010 | Other | Potential for bright artifacts to appear on the patient image from a previous exposure. |
| Jul 23, 2007 | Not classified | Z-0910-2007 | 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?
- The line of descent spans 11 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.
- Of its descendants, K173433 (Philips Medical Systems Dmc GmbH, 2018) has gone furthest, with 2 descendants of its own.
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?
The Philips EasyDiagnost Eleva intended use is for the following applications: as a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. This includes the following examples:
Routine Examinations
Colon examinations
Examinations of the digestive tract
Lung fluoroscopy
Examinations of the gall bladder
Thorax examinations
Skeleton imaging
Pediatric examinations
Special Applications (might require special accessories and technique)
Angiography
Myelography
Phlebography
Arthrography
Bronchography
Tomography
Sialography
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/K031535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031535: Philips Easydiagnost Eleva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031535
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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