Radiology picture archiving and communication system application software

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Beszerezhető a:

AA-Med Pty Ltd

Osztály:

Class Im

Gyártó:

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

Terápiás terület:

41670 - Radiology picture archiving and communication system application software

Terápiás javallatok:

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.

Engedélyezési státusz:

A

Engedély dátuma:

2016-07-19