MDR & FDA Statement

The imito AG software (smartphone applications, web-based solutions and server-side components) is intended for medical and medico-administrative documentation (storage & archival), communication, simple search and data representation/embellishment.

    According to the European Union Medical Device Regulation (MDR) “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” and based on following intended purposes listed below, imito programs are not regulated by the European Union MDR.

    According to the United States FDA “Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, September 2019” and pursuant section 520(o)(1)(D) of the FD&C Act, software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data are not devices and are not subject to FDA laws and regulations applicable to devices. imito programs and their intended purposes listed below are within this definition (“Non-Device-MDDS”) and therefore not enforced by FDA to comply with the regulatory controls.

    imitoMeasure
    • Documentation of wounds, dermatological lesions, specimen, etc. (digital photo documentation).
    imitoScan
    • Scanning and archiving of medico-administrative reports and documents.
    imitoCam
    • Documentation of clinical pictures & movies, wounds (digital photo documentation).
    • Area measurement.
    • Storage, transfer and archival of data to the EHR (integration to EHR).
    • A communication system for Healthcare Professionals (commenting & mentioning).
    • Communication for DICOM modalities (Easy DICOM worklist).
    • Simple search support (Picture: manual tagging & search).
    imitoWound Cloud
    • Documentation of wounds (pictures, movies) (digital photo documentation).
    • Documentation of related wound status and therapy.
    • Wound measurement.
    • Communication system for Healthcare Professionals (sharing of documentation).
    • Simple search support (picture: manual tagging & search).
    imitoWound Enterprise
    • Documentation of wounds (pictures, movies) (digital photo documentation).
    • Wound measurement.
    • Documentation of related wound status and therapy.
    • Storage, transfer and archival of data to the EHR (Integration to EHR).
    • Communication system for Healthcare Professionals (commenting & mentioning).
    • Simple search support (picture manual tagging & search).
    imitoWeb
    • Documentation of clinical pictures & movies, wounds (digital photo documentation).
    • Storage, transfer and archival of data to the EHR (integration to EHR).
    • Communication system for healthcare professionals (commenting & mentioning).
    • Communication system to PACS (Easy DICOM worklist).
    • Simple search support (picture: manual tagging & search).
    imitoDashboard
    • Administration of imito Documentation software (No Medical Device software administration).