Data / Medical devices / Japan / M-Solutions Inc.

M-Solutions Inc.: FDA-registered device maker in Tokyo, Japan, 3 510(k) clearances and 1 PMA approval

Name: M-Solutions Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

M-Solutions Inc. is registered with the FDA (registration 3013875850) in Tokyo, Japan. It lists 6 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated June 27, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013875850
Address: 2-16-2 MinamiShinozakiMachi Edogawa-ku, Tokyo, Japan, 1330065
Owner or operator: M-solutions Inc. (10055621)
Roles: Exporter to the US
First device listed: August 24, 2017
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Exporter to the US	accessdata.fda.gov
Device, Beam Limiting, X-Ray, Diagnostic	KPW	2	Exporter to the US	accessdata.fda.gov
Digital Breast Tomosynthesis	OTE	3	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 27, 2019	K190578	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence	JAK	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
September 20, 2012	K121676	1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 19, 2011	K093581	DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 11, 2011	P080003	SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	OTE	10	November 24, 2025	accessdata.fda.gov

Compare with other makers

Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.