Zenition 50

• • Ongoing Z-0241-2026 FDA Class II ·initiated 29 Sep 2025

  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.

• • Ongoing Z-1580-2025 FDA Class II ·initiated 25 Feb 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.

• • Ongoing Z-0352-2025 FDA Class II ·initiated 7 Oct 2024

  Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

• • Ongoing Z-0226-2024 FDA Class II ·initiated 4 Oct 2023

  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 Spacer (Tube-spacer) is missing.

• • Ongoing Z-0647-2022 FDA Class II ·initiated 2 Dec 2021

  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 switch is not used or if the wired foot switch is not connected to the system.

• • Terminated Z-1932-2020 FDA Class II ·initiated 10 Apr 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 happens, live parts may be exposed (230 V) and/or the video signal can be lost.

510(k) Number

K183101 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Azurion upgrade to R4

  Class IIb

  CE/MDR

• Marlin 1.5T

  Class IIb

  CE/MDR 2243595CE01 Active Valid to May 2030

• Zenition 30

  Class II

  FDA 510(k) K254205 Active Cleared 7 Aug 2026

• dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

  Class II

  FDA 510(k) K262330 Active Cleared 30 Jul 2026

• dS FootAnkle 16Ch 1.5T

  Class II

  FDA 510(k) K262294 Active Cleared 24 Jul 2026

• Multimodality Simulation Workspace (MM Sim) Upgrade

  Class IIb

  CE/MDR GUDID on market

See all devices from Philips Medical Systems Nederland B.V. →

• What types of procedures is the Zenition 50 designed to support with its real-time imaging capabilities?

  The Zenition 50 is specifically designed for real-time imaging during surgical and interventional procedures in fields like orthopedics, cardiology, and vascular interventions. Its mobile C-arm configuration with an integrated image intensifier provides high-quality fluoroscopic views, making it ideal for guiding precise interventions in settings such as operating rooms, catheterization labs, and interventional radiology suites.

• Is the Zenition 50 a single-use or reusable device, and what does this mean for maintenance and costs?

  The Zenition 50 is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. This design reduces per-procedure costs but requires adherence to manufacturer guidelines for reprocessing to ensure safety, sterility, and performance consistency over multiple uses.

• How is the Zenition 50 regulated, and what does this imply for its use in clinical settings?

  The Zenition 50 is authorized under both FDA 510(k) clearance and the EU’s Medical Device Regulation (MDR), classifying it as a Class II device. This regulatory pathway ensures it meets stringent safety and performance standards for interventional fluoroscopic systems, allowing its use in clinical settings where portability and flexibility are critical, such as ORs and catheterization labs.

• What storage and handling requirements should be followed for the Zenition 50 to maintain its functionality?

  While specific storage details aren’t provided, as a reusable fluoroscopic system, the Zenition 50 should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and electromagnetic interference. Manufacturer guidelines likely include regular maintenance checks and calibration to ensure optimal imaging quality and safety during use.

• Does the Zenition 50 come with multiple configurations or models, and how might this affect procedure planning?

  The Zenition 50 is described as a single interventional fluoroscopic system with a mobile C-arm design, but it includes multiple FEI (Facility Equipment Identifier) and registration numbers, suggesting compliance tracking across various institutional setups. While no specific models are mentioned, its adaptability for orthopedics, cardiology, and vascular procedures implies versatility in procedure planning, though exact configurations would depend on institutional customization or accessories.