Cleared Traditional

2MP Monochrome LCD Monitor MS-S200

K210345 · Jvckenwood Corporation · Radiology

Apr 2021

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K210345 is an FDA 510(k) clearance for the 2MP Monochrome LCD Monitor MS-S200, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Jvckenwood Corporation (Yokohama, JP). The FDA issued a Cleared decision on April 23, 2021, 77 days after receiving the submission on February 5, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K210345 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2021
Decision Date	April 23, 2021
Days to Decision	77 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.