Device Dossier

Clinical data collection/management information application software

Device Dossier for Clinical data collection/management information application software (Clinical data collection/management information application…

Intended purpose

The reader software is used post-procedure, it enables a user to view recordings on a computer that is not the part of the recording device. The recordings are intended for a user to visualise the size and pressure estimates of the gastro-intestinal tract. Note, the reader is for viewing of recordings only, it is not the user interface of the recording device.

TGA Public Summary