Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013875850

FEI Number

3013875850

Entity Name

M-SOLUTIONS INC.

City/State/Country

Tokyo, JP

Establishment Address

2-16-2 MinamiShinozakiMachi, Edogawa-ku, Tokyo 1330065, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

M-solutions Inc. (Owner Number: 10055621)

Owner / Operator Contact Address

2-16-2 MinamiShinozakiMachi, Edogawa-ku, JP-13 1330065, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190578

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTE	Digital Breast Tomosynthesis	Unknown	Class 3	N/A	2025-05-29
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-04-03
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-04-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-04-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

M-solutions Inc.

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
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-2219-2025	FUJIFILM Healthcare Americas Corporation	3	ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524

Similar Registrations

Registration Number	Establishment Name	Location
3040678329	PRIMEX MEDICAL PTY LTD	Wembley Western Australia, AU
3008496839	EvERX PTY LTD	Sydney New South Wales, AU
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP
3012127758	Siemens Healthcare Limited	Oakville Ontario, CA
3036666444	FUJITA CO., LTD.	Chiyoda-ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013875850. Last updated year: 2026. Please use registration number 3013875850 when referencing this establishment in official correspondence.