# K183101: Zenition 50

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Dec 31, 2018 after 54 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010435 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010435: Philips BV Pulsera/Endura, Philips Medical Systems, Inc. (2001) Summary page 4.

## Recalls of this device
- Sep 29, 2025 · Class II · Z-0241-2026: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
- Feb 25, 2025 · Class II · Z-1580-2025: 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 7, 2024 · Class II · Z-0352-2025: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
- 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
- Dec 2, 2021 · Class II · Z-0647-2022: 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-1932-2020: 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 50 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/K183101
Methodology: https://510kreport.com/methodology