MDR & FDA Statement
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Produkte
imitoCam app icon
imitoCam
Medizinische Foto- und Videodokumentation
imitoWound app icon
imitoWound
Wunddokumentation & Wundvermessung mit KI
imitoScan app icon
imitoScan
Scan-App für Patientendokumente
imitoMeasure app icon
imitoMeasure
Wundvermessung zum Testen

Anwendungsfälle
Medizinische Foto- und Videodokumentation
Zweitmeinungen einholen
Forschung und Lehre
Dokumente Scannen
KIS, DMS und PACS Integration
EasyWorklist
Wunddokumentation

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MDR & FDA Statement

  1. imitoWound 3.0
  2. imitoCam
  3. imitoScan
  4. imitoMeasure
  5. Cutimed Wound Navigator

imitoWound 3.0

Intended Use

Our app imitoWound 3.0 and its server and web components are designed for health care professionals for the purpose of documenting wounds & stomas (digital wound documentation). It is intended for medical and medico-administrative documentation (storage & archival), communication, simple search and data representation/embellishment.

The main features include:

  • Simple search
  • Photo capturing with image calibration (calibration markers or rulers support)
  • Documentation of wound size, based on photographs
  • Documentation of wound status and therapy
  • Storage, transfer and archival of data to the EMR (integration to EMR)
EU and Switzerland

imitoWound 3.0 is not a medical device as per “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” according to its intended use.

imitoWound 3.0 and its server and web components are intended for medical and medico-administrative documentation and data representation, and therefore, is not regulated by the European Union MDR.

imitoCam

Intended Use

Our app imitoCam and its server and web components are designed for health care professionals for the purpose of enriching medical documentation with photos and videos. It is intended for medical and medico-administrative documentation and data representation.

The main features include:

  • Documentation of clinical pictures & movies, wounds (digital photo documentation).
  • Documentation of the size of wounds or other medical issues, based on photographs
  • Storage, transfer and archival of data to the EMR (integration to EMR).
  • A communication system for Healthcare Professionals (commenting & mentioning).
  • Communication for DICOM modalities (Easy DICOM worklist).
  • Simple search support (Picture: manual tagging & search).
EU and Switzerland

imitoCam is not a medical device as per “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” according to its intended use.

imitoScan

Intended Use

Our app imitoScan and its server and web components are designed for healthcare professionals and healthcare administrators for the purpose of maintaining complete patient documentation.

Its main feature is:

  • Scanning and archiving of medico-administrative reports and documents.

imitoMeasure

Intended Use

Our app imitoMeasure is designed for digital photo documentation of various medical conditions and area measurement where it is relevant.

Its main features are:

  • Documentation of wounds, dermatological lesions, specimens, etc as a PDF file
  • Documentation of the size of medical conditions, based on photographs

Cutimed Wound Navigator

Intended Use

The app is intended for documentation (storage & archiving / filing), communication, simple search and data representation/improvement. It does not recommend products, but only filters Essity products from an Essity product catalogue based on the input of the health care professional. This output is afterwards open to the interpretation of the respective health care professional.

EU, Switzerland, and other Countries

The app is not a medical device according to EU MDR & and other internal laws (i.a. RSA, Australia, Canada and beyond) because of its intended use.

imito AG
Ⓒ imito AG 2016–2024