Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610982

FEI Number

3002807605

Entity Name

MIKASA X-RAY CO., LTD.

City/State/Country

Yokohama-shi Kanagawa, JP

Establishment Address

2-7-2 Shirotaecho, Minami-ku,, Yokohama-shi Kanagawa 2320023, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MIKASA X-RAY CO., LTD. (Owner Number: 8030220)

Owner / Operator Contact Address

2-7-2 Shirotaecho, Minami-ku,, --, Yokohama-shi, JP-14 232-0023, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052721

PMA Number

N/A

All Registered Proprietary Names

TR90BH portable battery operated medical x-ray unit MinXray HF120/60HPPWV HF1202H PowerPlus MinXray HF100H+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2019-01-04
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	1979-04-26
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2016-08-19
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	1979-04-26

Official Correspondent

SHUJI SHINAGAWA

US Agent Details

MARK MILLER Business: MINXRAY, INC. Email: mmiller@minxray.com Phone: (847) 5640323

Related Public Records

Same Entity

MIKASA X-RAY CO., LTD.

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
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Similar Registrations

Registration Number	Establishment Name	Location
3005246977	POSKOM CO., LTD	Goyang-si Gyeonggi, KR
3031503890	BLOCK IMAGING PARTS & SERVICE	Holt, MI, US
3011491794	ECOTRON Co., Ltd.	Seoul, KR
3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN
2126677	GE MEDICAL SYSTEMS, LLC	Waukesha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610982. Last updated year: 2026. Please use registration number 9610982 when referencing this establishment in official correspondence.