imito Software Apps and Solutions

Our apps and programs are not regulated by the European Union MDR. These smartphone applications, web-based solutions, server-side components, and mobile SDK are 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.

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.

imitoCam

• Documentation of clinical pictures & movies, wounds (digital photo documentation).
• Area measurement.
• 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).

imitoScan

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

imitoMeasure

• Documentation of wounds, dermatological lesions, specimens, etc. (digital photo documentation).

imitoWound 3.0

• Documentation of wounds & stoma (digital wound documentation).
• Wound area measurement.
• Storage, transfer and archival of data to the EMR (integration to EMR).
• Simple search support

WoundGenius 1.0 (Mobile SDK)

• Image capture of wounds, dermatological lesions, specimens, etc.
• Area Measurement.
• Transfer of data (image, metadata) to the mobile app

Cutimed Wound Navigator

The app is not regulated by the European Union MDR because its intended use is not a medical one. It is intended for documentation (storage & archiving / filing), communication, simple search and data representation/improvement and is limited to providing information about BSN Products comparable to a catalogue which is subject to interpretation by a health care professional.