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Image One

by Infomed Software, S.L.

510(k) K250716

Active European Union and United States

CE MDR 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) K250716↗

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 NumberK250716 Date23 Jul 2025ClearedStatusActive
European UnionCE/MDR 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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
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 IMAGE ONE is a Medical Image Management and Processing System (Product Code LLZ) designed for the acquisition, storage, retrieval, and analysis of medical imaging data. It facilitates workflow integration across radiology, dental, and clinical settings by enabling secure digital handling of images such as X-rays, MRIs, and CT scans, while supporting diagnostic and treatment planning functions.

This system is supplied as software for use on cloud or desktop platforms, requiring no physical sterilisation or single-use considerations. It operates within regulatory frameworks including FDA 510(k) clearance (K250716) and MDR compliance, with no MRI safety restrictions specified. Deployment requires compatible hardware and network infrastructure, adhering to 21 CFR 892.2050 standards for Class II medical devices.

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 types of medical imaging data can the IMAGE ONE system handle, and how does it integrate with different clinical workflows?

    The IMAGE ONE system is designed to manage and process a wide range of medical imaging data, including X-rays, MRIs, and CT scans. It supports workflow integration across radiology, dental, and clinical settings by providing secure digital handling of these images. This enables efficient storage, retrieval, and analysis, which aids in diagnostic processes and treatment planning. The system is software-based and works on cloud or desktop platforms, ensuring flexibility for various clinical environments.

  • Is the IMAGE ONE system single-use, or is it intended for repeated use in a clinical setting?

    The IMAGE ONE system is a software-based solution and does not require physical sterilization or single-use considerations. Since it operates on cloud or desktop platforms, it is designed for repeated use within compatible hardware and network infrastructure, adhering to regulatory standards for Class II medical devices.

  • What hardware and infrastructure requirements must be met to deploy the IMAGE ONE system in a clinical environment?

    Deployment of the IMAGE ONE system requires compatible hardware and a stable network infrastructure to support its cloud or desktop operation. While the system itself does not have physical sterilization or single-use constraints, it must comply with regulatory standards such as 21 CFR 892.2050 for Class II medical devices. Ensure your facility’s IT setup aligns with these requirements for seamless integration.

  • How does the IMAGE ONE system ensure secure handling of sensitive medical imaging data?

    The IMAGE ONE system is designed to facilitate secure digital handling of medical imaging data, including X-rays, MRIs, and CT scans. While the specific security protocols are not detailed in the provided data, its regulatory compliance (including FDA 510(k) clearance and MDR) suggests adherence to industry standards for data protection and integrity. This ensures that sensitive patient information remains confidential and secure during storage, retrieval, and analysis.

  • What regulatory pathways does the IMAGE ONE system follow, and how does this impact its use in clinical settings?

    The IMAGE ONE system follows regulatory pathways including FDA 510(k) clearance (K250716) and MDR compliance, indicating it has undergone evaluations for safety and effectiveness as a Class II medical device. This clearance ensures it meets established standards for medical image management and processing systems, allowing clinicians to rely on its performance for diagnostic and treatment planning purposes. The system’s compliance also aligns with broader regulatory frameworks, ensuring consistent use across clinical environments.