# K142708: Veradius Unity

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nethrlands BV
- Decided: Oct 22, 2014 after 30 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: 4 generations back to K042646 (2004). 4 ancestors in all.
11 later devices descend from it; 3 cite 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)
- K133819: Veradius, Philips Medical Systems Nederland B.V. (2014) Summary page 4.

## Most influential descendants
- 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
- K232420: Zenition 30 (2024), 1 descendant of its own

## Recalls of this device
- Feb 25, 2025 · Class II · Z-1582-2025: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Oct 4, 2023 · Class II · Z-0230-2024: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance S
- Dec 2, 2021 · Class II · Z-0649-2022: Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand s
- Nov 12, 2021 · Class II · Z-0357-2022: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as r

## Indications for use
The Veradius Unity 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 one 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 non-sterile environments, in a variety of procedures. Applications * Orthopedic * Neuro * Abdominal * Vascular * Thoracic * Cardiac

Source page: https://510kreport.com/device/K142708
Methodology: https://510kreport.com/methodology