Image One

Primary DI

08437025164004

Basic UDI-DI Code

8437025164IMAGEONEW5

Reference

07

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Infomed Software SL

IMAGE ONE software is an image management software which runs in a browser containing a user interface that allows the dentist to access and display patients’ images or videos that have been taken during the course of a clinical practice. IMAGE ONE is cloud-based Software which runs in a web browser with no access to hardware devices. The only way that IMAGE ONE may retrieve files is by requesting them from the file system of the Operating System. There are two scenarios involving the abovementioned files. In the first one, the files may have been generated in the past by an external system, in which case IMAGE ONE allows the user to import and catalog them immediately. The other one is when the files do not exist yet and are going to be generated during a clinical procedure by an external system. The user can request IMAGE ONE to wait for the user to complete an external acquisition process before importing and cataloging the files automatically. IMAGE ONE software supports image and video standards commonly used in dentistry to date. These include X-ray radiographic images in PNG, JPEG, or BMP format, 3D models in STL format obtained from intraoral scans, intraoral video in MP4 format, and computed tomography images in DICOM format. In addition to its image management functions, the software also offers through its user interface a visualization enhancement function (zoom and filters functions) for X-ray radiographic images in either PNG, JPEG, or BMP format. An additional distance measuring function is also included but strictly restricted to X-ray radiographic images in format PNG, JPEG, or BMP displaying a calibrator.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).