Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000207387

FEI Number

1000207387

Entity Name

JVCKENWOOD Corporation

City/State/Country

Yokohama-shi Kanagawa, JP

Establishment Address

3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi Kanagawa 221-0022, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

JVCKENWOOD Corporation (Owner Number: 10044588)

Owner / Operator Contact Address

3-12, Moriya-cho, Kanagawa-ku,, Yokohama-shi,, JP-14 221-0022, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191137

PMA Number

N/A

All Registered Proprietary Names

MS-S300 CL-R813 MS-S200 CL-S1200 CL-S300 CL-S200 CL-S600 CL-R211 MS-S500 CL-S500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2020-02-24
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-12-22
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2021-04-25
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2021-06-29
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-12-14
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2021-12-17
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2018-10-16
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2019-07-03

Official Correspondent

No official correspondent registered.

US Agent Details

Angie Seay Business: JVCKENWOOD USA Corporation Email: aseay@us.jvckenwood.com Phone: (678) 4498879

Related Public Records

Same Entity

JVCKENWOOD Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000207387. Last updated year: 2026. Please use registration number 1000207387 when referencing this establishment in official correspondence.