Instrument/analyser IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
28-05-2019

Saadav alates:

Philips Electronics Australia Ltd

Klass:

Class 1

Valmistatud:

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

Terapeutiline ala:

CT943 - Instrument/analyser IVDs

Näidustused:

The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS comprises the Image Management System (IMS) and the Ultra Fast Scanner (UFS). The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.

Volitamisolek:

Included - IVD

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