# K133819: Veradius

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jul 10, 2014 after 206 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: 3 generations back to K042646 (2004). 3 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090590: Veradius, Model 718-130, Philips Medical Systems North America Co. (2009) Summary page 1.

## Most influential descendants
- K142708: Veradius Unity (2014), 11 descendants of its own
- K183040: Zenition 70 (2018), 6 descendants of its own
- K230871: Extron 5; Extron 7 (2023), 3 descendants of its own
- K212813: Zenition 70 (2021), 3 descendants of its own
- K250010: Extron 3; Extron 5; Extron 7 (2025), 1 descendant of its own

## Indications for use
The Veradius device is intended to be used and operated by: adequately trained. qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, radiologists, and radiographers. who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic. interventional. and surgical procedures on all patients except neonates (birth to I month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, in sterile as well as nonsterile environments, in a variety of procedures. Applications * Orthopedic * Neuro * Abdominal tVascular * Thoracic "Cardiac

Source page: https://510kreport.com/device/K133819
Methodology: https://510kreport.com/methodology