Instrument/analyser IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
04-11-2017

Saadav alates:

Philips Electronics Australia Ltd

Klass:

Class 1

Valmistatud:

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

Terapeutiline ala:

CT943 - Instrument/analyser IVDs

Näidustused:

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.

Volitamisolek:

Included - IVD

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