Instrument/analyser IVDs

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:

Philips Electronics Australia Ltd

クラス:

Class 1

製:

Philips Electronics Nederland BV Digital Pathology Solutions Veenpluis 4-6, PC Best, 5684 Netherlands

治療領域:

CT943 - Instrument/analyser IVDs

適応症:

The Philips IntelliSite Pathology Solution (PIPS) is intended for in vitro diagnostic use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides; The PIPS is an automated digital slide creation, management, viewing and analysis system. Note 1: The PIPS is for evaluation of digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls to assure the validity of the diagnosis provided by using PIPS. Note 2: The PIPS is not validated for frozen sections and hematopathology.

認証ステータス:

Included - IVD

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