Cleared Abbreviated

Zenition 30

K232420 · Philips Medical Systems Nederland B.V. · Radiology

Feb 2024

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K232420 is an FDA 510(k) clearance for the Zenition 30, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on February 16, 2024, 189 days after receiving the submission on August 11, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K232420 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2023
Decision Date	February 16, 2024
Days to Decision	189 days
Submission Type	Abbreviated
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy