# K031535: Philips Easydiagnost Eleva

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems North America Co.
- Decided: Jun 17, 2003 after 32 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924593 (1992). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970640: Philips Easy Diagnost, Philips Medical Systems North America, Inc. (1997) Summary page 2.

## Most influential descendants
- K173433: ProxiDiagnost N90 (2018), 2 descendants of its own
- K163210: Philips CombiDiagnost R90 (2017), 2 descendants of its own
- K212837: ProxiDiagnost N90 (2021), 1 descendant of its own
- K203087: CombiDiagnost R90 (2020), 1 descendant of its own
- K233945: ProxiDiagnost N90 / Precision CRF (706110, 706400) (2024), 0 descendants of its own

## Recalls of this device
- Sep 21, 2023 · Class II · Z-0279-2024: Potential for units suspended on the ceiling to fail and fall.
- Jun 2, 2020 · Class II · Z-2523-2020: 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: 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 
- Aug 19, 2014 · Class II · Z-0365-2016: 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- Oct 30, 2013 · Class II · Z-0431-2014: The delivered application software was an outdated version to the model of equipment.
- Jan 16, 2013 · Class II · Z-0767-2013: 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: 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: 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,
- Mar 9, 2012 · Not classified · Z-1283-2012: Underexposed image due to lag in switching between auxiliaries
- Feb 14, 2012 · Not classified · Z-1216-2012: 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: 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 registe
- Jan 21, 2009 · Not classified · Z-0479-2011: 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 
- Dec 10, 2008 · Not classified · Z-0353-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Jul 9, 2008 · Not classified · Z-2194-2010: Potential for bright artifacts to appear on the patient image from a previous exposure.
- Jul 23, 2007 · Not classified · Z-0910-2007: 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 pro

## Indications for use
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

Source page: https://510kreport.com/device/K031535
Methodology: https://510kreport.com/methodology