Cleared Traditional

3MP Color LCD Monitor (CL-S301)

K241105 · Jvckenwood Corporation · Radiology

Aug 2024

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K241105 is an FDA 510(k) clearance for the 3MP Color LCD Monitor (CL-S301), a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Jvckenwood Corporation (Yokohama, JP). The FDA issued a Cleared decision on August 1, 2024, 101 days after receiving the submission on April 22, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K241105 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2024
Decision Date	August 01, 2024
Days to Decision	101 days
Submission Type	Traditional
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.