Cleared Special

Coronis OneLook

K242008 · Barco N.V. · Radiology

Aug 2024

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K242008 is an FDA 510(k) clearance for the Coronis OneLook, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on August 2, 2024, 23 days after receiving the submission on July 10, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K242008 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PGY — Display, Diagnostic Radiology
Device Class	Class II — 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.