# K183040: Zenition 70

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Dec 6, 2018 after 35 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K042646 (2004). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142708: Veradius Unity, Philips Medical Systems Nethrlands BV (2014) Summary page 5.

## Most influential descendants
- K212813: Zenition 70 (2021), 3 descendants of its own
- K232420: Zenition 30 (2024), 1 descendant of its own
- K222080: Garion Image-Intensified Fluoroscopic X-Ray System, Mobile (2022), 1 descendant of its own
- K254205: Zenition 30 (2026), 0 descendants of its own
- K243411: Diagnostic X-ray System (2025), 0 descendants of its own

## Recalls of this device
- Feb 25, 2025 · Class II · Z-1581-2025: 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-0226-2024: 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
- Jul 20, 2023 · Class II · Z-1583-2025: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- Dec 2, 2021 · Class II · Z-0648-2022: 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
- Apr 10, 2020 · Class II · Z-1933-2020: When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happe

## Indications for use
The Zenition 70 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals 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, 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/K183040
Methodology: https://510kreport.com/methodology