Barco MDPC-8127, User Manual, Page: 6 / 52

R5913216 /03 MDPC-8127 6
1.1 Regulatory compliance information
Indications for use
Barco digital pathology display is intended to display digital images of histopathology slides for review and
interpretation by trained medical practitioners.
For USA specifically: The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital
images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using
IVD-labeled digital pathology image viewing software that have been validated for use with this device. It is an
aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is
the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of
the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from
frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Intended usage environment
The device is intended for surgical pathology tasks performed in the anatomic pathology laboratory or a
physician
’ s office.
Contra-indications
The device is not intended for use with frozen section, cytology, or non-formalin-fixed paraffin embedded
(FFPE) hematopathology specimens.
Intended users
Barco pathology displays are intended to be used by trained medical practitioners.
The device is initially set up by trained integrators or medical IT staff.
Expected clinical benefits
The device aids in pathology diagnosis.
Notice to the user and/or patient
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
Factory addresses
• Barco NV , President Kennedypark 35, 8500 Kortrijk, Belgium
• Fimi S.r.l. , Via Saul Banfi 1, 21047 Saronno, VA, Italy
Manufacturing country
The manufacturing country of the product is indicated on the product label ( “ Made in …” ).
Importers contact information
To find your local importer, contact one of Barco ’ s regional offices via the contact information provided on our
website ( www.barco.com ).
FCC class B
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1)
this device may not cause harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference
in a residential installation. This device generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a particular installation. If
this device does cause harmful interference to radio or television reception, which can be determined by
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