Radiology picture archiving and communication system application software

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Dostupno od:

AA-Med Pty Ltd

Razred:

Class Im

Proizveden od:

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

Područje terapije:

41670 - Radiology picture archiving and communication system application software

Terapijske indikacije:

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 autorizacije:

A

Datum autorizacije:

2016-07-19