# K232420: Zenition 30

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Feb 16, 2024 after 189 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: 7 generations back to K042646 (2004). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K212813: Zenition 70, Philips Medical Systems Nederland B.V. (2021) Summary page 5.

## Most influential descendants
- K254205: Zenition 30 (2026), 0 descendants of its own

## 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/K232420
Methodology: https://510kreport.com/methodology