Cleared Special

K242008 - Coronis OneLook (FDA 510(k) Clearance)

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

K242008 · Barco N.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
23d
Days
Class 2
Risk

K242008 is an FDA 510(k) clearance for the Coronis OneLook. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on August 2, 2024 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Barco N.V. devices

Submission Details

510(k) Number K242008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2024
Decision Date August 02, 2024
Days to Decision 23 days
Submission Type Special
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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
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 - PGY Display, Diagnostic Radiology

All 133
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K242008.
LCD Monitor (CL1902A, CL2103F)
K252780 · Shenzhen Beacon Display Technology Co., Ltd. · Dec 2025
LCD Monitor (C1216W, C822W, C821W)
K253242 · Shenzhen Beacon Display Technology Co., Ltd. · Oct 2025
RadiForce GX570
K252030 · Eizo Corporation · Aug 2025
RadiForce RX570
K243221 · Eizo Corporation · Nov 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K243031 · Shenzhen Beacon Display Technology Co., Ltd. · Oct 2024
3MP Color LCD Monitor (CL-S301)
K241105 · Jvckenwood Corporation · Aug 2024