# K982993: Philips Omnidiagnost

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Sep 29, 1998 after 33 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912470 (1991). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K912470: Philips Diagnost 96, Philips Medical Systems, Inc. (1991) Summary page 1.

## Most influential descendants
- K032046: Phillips Omnidiagnost Eleva (2003), 2 descendants of its own
- 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
- Feb 28, 2019 · Class II · Z-1054-2019: 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-2301-2018: 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
- Jul 6, 2009 · Not classified · Z-1665-2009: The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch
- Jul 17, 2003 · Not classified · Z-0874-03: Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).

## Indications for use
The Philips OmniDiagnost is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

Source page: https://510kreport.com/device/K982993
Methodology: https://510kreport.com/methodology