# K032046: Phillips Omnidiagnost Eleva

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Jul 17, 2003 after 15 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912470 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982993: Philips Omnidiagnost, Philips Medical Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K092713: Spectre Wireless Encrypted Footswitch and Hand Switch System (2010), 0 descendants of its own
- K050692: FLXIS (2005), 0 descendants of its own

## Recalls of this device
- Dec 30, 2019 · Class II · Z-1490-2020: 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: 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: 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
- Oct 7, 2010 · Not classified · Z-1657-2011: 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: 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
- Dec 10, 2008 · Not classified · Z-0352-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Mar 22, 2008 · Not classified · Z-1374-2008: 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: 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 OmniDiagnost Eleva is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

Source page: https://510kreport.com/device/K032046
Methodology: https://510kreport.com/methodology