Radiology DICOM image processing application software

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

AA-Med Pty Ltd

Klass:

Class IIb

Tillverkad av:

EKO AI Pte Ltd 2 College Road 02-00, Singapore, 169850 Singapore

Terapiområde:

57812 - Radiology DICOM image processing application software

Terapeutiska indikationer:

Us2.v1 is a software platform that automatically processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making based on DICOM images produced by FDA approved ultrasound devices. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).

Bemyndigande status:

A

Tillstånd datum:

2022-01-06