Radiology picture archiving and communication system application software

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

AA-Med Pty Ltd

Classe:

Class Im

Fabricado por:

Volpara Health Technologies Limited Level 14 Simpl House 40 Mercer Street, Wellington Central, Wellington, 6011 New Zealand

Área terapêutica:

41670 - Radiology picture archiving and communication system application software

Indicações terapêuticas:

Software application intended for use with raw data from digital breast x-ray systems, including tomosynthesis, to determine volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates which assists radiologists in their assessment of breast tissue composition. The device provides adjunctive information; it is not an interpretive or diagnostic aid. The device can also derive the radiation dose absorbed by the specific breast being imaged, which is used for quality control purposes.

Status de autorização:

A

Data de autorização:

2016-07-19