Cleared Abbreviated

K232420 - Zenition 30 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K232420 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
189d
Days
Class 2
Risk

K232420 is an FDA 510(k) clearance for the Zenition 30. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on February 16, 2024 after a review of 189 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K232420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 107d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 318
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K232420.
Intelligent NR
K252503 · Canon, Inc. · Apr 2026
ARTIS icono floor
K254173 · Siemens Medical Solutions USA, Inc. · Apr 2026
ARTIS genio floor
K253752 · Siemens Medical Solutions USA, Inc. · Apr 2026
BELLIGER ACE
K252229 · Genoray Co., Ltd. · Apr 2026
Trinias
K252099 · Shimadzu Corporation · Mar 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
K253584 · Canon Medical Systems Corporation · Mar 2026