Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
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Intended Purpose
The Aperio GT 450 DX is a device for creation of digital images of scanned surgical pathology glass slides prepared from
formalin-fixed paraffin embedded (FFPE) tissue that would otherwise be appropriate for manual visualization by conventional
light microscopy. Aperio GT 450 DX is intended for in vitro diagnostic use with compatible viewing software and display that
has been validated for use with this scanner as an aid to the pathologist in the qualitative review and interpretation of digital
images.
The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. 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 the Aperio GT 450 DX.
Symbols
The following symbols appear on your product label or in this user guide.
Symbol
Regulation/
Standard
Description
ISO 15223-1 - 5.4.3
Consult the instructions for use.
ISO 15223-1 - 5.1.1
Manufacturer
ISO 15223-1 - 5.1.3
Date of manufacture
ISO 15223-1 - 5.1.2
European Union Authorized Representative
ISO 15223-1 - 5.1.8
Importer
AS/NZS 4417.1
Device is in compliance with with the Australian Communications Media
Authority (ACMA) requirements (safety and EMC) for Australia and New
Zealand.
ISO 15223-1 - 5.1.7
Serial number
ISO 15223-1 – 5.5.1
In Vitro Diagnostic medical device.
ISO 15223-1 – 5.1.6
Catalog number
ISO 15223-1 – 5.7.10
Unique Device Identifier
EU 2017/746
Article 18
Device carries the CE (Conformité Europëenne) Mark and fulfils the
requirements of EU Regulation 2017/746.
