Cleared Traditional

K203733 - 12MP Color Digital Mammography LCD Monitor CL-S1200
(FDA 510(k) Clearance)

K203733 · Jvckenwood Corporation · Radiology

Jun 2021

Decision

190d

Days

Class 2

Risk

K203733 is an FDA 510(k) clearance for the 12MP Color Digital Mammography LCD Monitor CL-S1200, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Jvckenwood Corporation (Yokohama, JP). The FDA issued a Cleared decision on June 29, 2021, 190 days after receiving the submission on December 21, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K203733 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2020
Decision Date	June 29, 2021
Days to Decision	190 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.