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Mobile X-ray Unit (!M1)

by Solutions for Tomorrow Ab

510(k) K251710

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251710↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK251710 Date24 Oct 2025ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mobile X-ray Unit (!M1) is a portable radiographic imaging system designed for capturing high-quality X-ray images in various clinical settings. It is classified as a mobile X-ray system, enabling radiography outside fixed facilities such as operating rooms, emergency departments, or patient bedsides. The device facilitates real-time diagnostic imaging for conditions requiring immediate assessment, including fractures, internal bleeding, or other acute abnormalities.

This unit is supplied as a reusable medical device and is intended for use in radiology departments or emergency care environments. It operates under regulatory oversight, including FDA 510K clearance and compliance with the Medical Devices Directive (MDD). The device is not classified as MRI-safe or MRI-conditional, and its specifications include multiple FEI numbers (e.g., 3015223550) and registration numbers for traceability. Storage and handling follow standard protocols for radiographic equipment to ensure operational integrity and patient safety.

Other devices from Solutions for Tomorrow Ab

  • Mobile wallstand

    Class I

  • !M1

    Class IIb

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical environments is the Mobile X-ray Unit (!M1) designed to operate in and why?

    The Mobile X-ray Unit (!M1) is specifically designed for use in environments where fixed radiographic equipment is impractical, such as operating rooms, emergency departments, or patient bedsides. Its portability enables real-time diagnostic imaging for acute conditions like fractures, internal bleeding, or other urgent abnormalities that require immediate assessment outside traditional radiology suites.

  • Is the Mobile X-ray Unit (!M1) intended for single-use or reusable applications, and how does this affect its maintenance?

    The Mobile X-ray Unit (!M1) is classified as a reusable medical device, meaning it is engineered for repeated use in clinical settings. This design requires adherence to standard protocols for cleaning, disinfection, and maintenance to ensure operational integrity, patient safety, and compliance with radiographic equipment standards.

  • What regulatory pathways has the Mobile X-ray Unit (!M1) followed, and what does this imply for its use?

    The Mobile X-ray Unit (!M1) has undergone FDA 510(k) clearance and complies with the Medical Devices Directive (MDD), indicating it meets regulatory standards for safety and performance in the U.S. and EU markets. This implies it has been evaluated for substantial equivalence to predicate devices and adheres to strict manufacturing and quality control requirements, ensuring reliability for clinical use.

  • How should the Mobile X-ray Unit (!M1) be stored, and what considerations should be taken into account?

    The Mobile X-ray Unit (!M1) should be stored following standard protocols for radiographic equipment to preserve its functionality and ensure patient safety. This includes protecting it from physical damage, extreme temperatures, and environmental contaminants. Proper storage also involves securing cables, maintaining calibration, and following manufacturer guidelines to avoid degradation of imaging quality or operational failures.

  • What does the inclusion of multiple FEI numbers and registration numbers indicate about the Mobile X-ray Unit (!M1)?

    The multiple FEI (Facility Establishment Identifier) numbers and registration numbers associated with the Mobile X-ray Unit (!M1) reflect its traceability and compliance with regulatory tracking systems. These identifiers allow healthcare facilities to verify the device’s authenticity, ensure proper inventory management, and maintain records for maintenance, recalls, or inspections as required by regulatory bodies like the FDA.