# K212813: Zenition 70

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Oct 1, 2021 after 28 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: 6 generations back to K042646 (2004). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183040: Zenition 70, Philips Medical Systems Nederland B.V. (2018) Summary page 4.

## Most influential descendants
- K232420: Zenition 30 (2024), 1 descendant of its own
- K254205: Zenition 30 (2026), 0 descendants of its own
- K240224: Zenition 90 (2024), 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 7, 2024 · Class II · Z-0353-2025: 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
- 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.

## Indications for use
The proposed Zenition 70 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/K212813
Methodology: https://510kreport.com/methodology