Zenition 30— 510(k) K254205
Substantially EquivalentPhilips Medical Systems Nederland B.V.
FDA 510(k) clearance K254205 for Zenition 30, Substantially Equivalent on 2026-08-07. Applicant: Philips Medical Systems Nederland B.V.. Device class: 2.
Summary
Philips Medical Systems Nederland filed the Zenition 30 under product code OWB, interventional fluoroscopic x-ray systems. The record gives no other model numbers.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Philips filed from Best, Netherlands. The decision came 221 calendar days after receipt (December 29, 2025 to August 7, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Philips Medical Systems Nederland B.V.
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Best, NL
Recent devices under product code OWB
view allMore clearances from Philips Medical Systems Nederland B.V.
view all- K262330 — 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
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K253614 — EchoNavigator R5.0
- K260169 — AV Cardiac CT
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.