# K254205: Zenition 30

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 7, 2026 after 221 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K042646 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232420: Zenition 30, Philips Medical Systems Nederland B.V. (2024) Summary page 5.

## Indications for use
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: * Orthopedic * Neuro » Abdominal » Vascular * Thoracic *» Cardiac

Source page: https://510kreport.com/device/K254205
Methodology: https://510kreport.com/methodology