Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010281549

FEI Number

3010281549

Entity Name

J. MORITA MFG. CORP., TOTTORI FACTORY

City/State/Country

Kurayoshi Tottori, JP

Establishment Address

608 Tani, Kurayoshi Tottori 682-0954, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

J. MORITA MFG. CORP. (Owner Number: 9048647)

Owner / Operator Contact Address

680 HIGASHIHAMA MINAMI-CHO,, FUSHIMI-KU, KYOTO, JP-NOTA 612-8533, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103697

PMA Number

N/A

All Registered Proprietary Names

Veraview FX800 Model X800N Veraview X800 STERLING XLR8 Plus ARETE Midwest 45 HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWINPOWER TURBINE 4H) TORQTECH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-02-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-02-23
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-02-23
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2017-12-27
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2017-12-27
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	Class 1	872.4200	2006-09-06
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2012-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

KEITH Barritt Business: FISH & RICHARDSON P.C. Email: barritt@fr.com Phone: (202) 7835070

Related Public Records

Same Entity

J. MORITA MFG. CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002807636	J. MORITA MFG. CORP.	FUSHIMI-KU Kyoto, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010281549. Last updated year: 2026. Please use registration number 3010281549 when referencing this establishment in official correspondence.