Radiology picture archiving and communication system application software

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
04-11-2017

から入手可能:

AA-Med Pty Ltd

クラス:

Class Im

製:

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

治療領域:

41670 - Radiology picture archiving and communication system application software

適応症:

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.

認証ステータス:

A

承認日:

2016-07-19

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