Cleared Traditional

8MP Color LCD Monitor CL-R813

K222864 · Jvckenwood Corporation · Radiology

Dec 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K222864 is an FDA 510(k) clearance for the 8MP Color LCD Monitor CL-R813, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Jvckenwood Corporation (Yokohama, JP). The FDA issued a Cleared decision on December 21, 2022, 90 days after receiving the submission on September 22, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K222864 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2022
Decision Date	December 21, 2022
Days to Decision	90 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.