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MetaSystem Metafer - Product Variants; Neon Client License Variants; Metafer - Intended Use; Metafer - Legal Classification

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Quick Guide
8
Product Variants
Besides the (full) Neon client licenses which come with every Ikaros, Isis or Metafer license,
additional Neon client licenses can be purchased. There are two Neon product variants:
and. It is possible to combine both license options to enable the full feature range:
Reference No.
Description
P-2500-002-MS
Neon Case Data Management (for Case Data entry)
P-2500-003-MS
Neon Gallery Reviews Upgrade (Enables Metafer and Ikaros/Isis Gallery, Counters and
Statistics views in the Case Window and reporting)
a If you have purchased any other Metafer and/or Ikaros / Isis license, both Neon vari-
ants are automatically included. Neon will start with Metafer and Ikaros galleries if at
least an Ikaros analysis or Metafer Review license is also available.
a The Combined Karyogram view is only accessible, if an Ikaros / Isis full or analysis li-
cense is available, too.
a If Neon is started with a network license, by default Neon tries to obtain the licenses
for the full functional range. You can start a Neon network license with the Case Data
Management license only, if you include command line argument /NoGalleryReview in
the desktop link.
Metafer
Intended Use
Metafer is intended to be used for the acquisition of microscopic images. Based on a mo-
torized microscope the slide scanning platform Metafer provides the tools for automating
the image acquisition process in brightfield as well as in fluorescence imaging. Multiple
slide positions can be sequentially relocated without user interaction in order to capture
the respective fields of view in a fully automated way. Metafer does not provide any re-
sults. It is the responsibility of the operator to interpret the images.
Legal Classification
MetaSystems products are used in many countries worldwide. Depending on the regula-
tions of the respective country or region, some products may not be used for clinical diag-
nostic use. In Europe, MetaSystems products are CE-labeled as in vitro diagnostic devices
(IVD):
EU
Australia
Brazil
Canada
Japan
U.S.A
Metafer
Micro /
Relosys
)
*
Class 2 / TGA
ARTG inclusion
Class 1 / Anvisa
DOU entry
Class 2 / License
(SOR-98-282)
MAH License no.
13B3X10527
Class 1 / Listing
Metafer
Modules
)
*
Class 2 / TGA
ARTG inclusion
Class 1 / Anvisa
DOU entry
Research Use
Only
MAH License no.
13B3X10527
Research Use
Only
* 98/79/EC IVD directive