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MetaSystem Metafer - Product Descriptions; System Components Overview; Neon - Intended Use; Neon - Legal Classification

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Quick Guide
7
Product Descriptions
MetaSystems products consist of software modules, hardware components and accesso-
ries in different configurations.
The entire system subject to this declaration consisting of specified, verified and validated
hardware components, software modules and their accessories after by Metasystems
specialists or authorized third parties.
Only components, modules and accessories specified, verified and validated by MetaSys-
tems can be replaced by MetaSystems specialists or authorized third parties as part of
maintenance or servicing.
Metafer V4.x and Ikaros / Isis V6.x strictly depend on Neon V1.x for case and data manage-
ment as well as for reporting (‘x’ represents the actual release version). Metafer and Ika-
ros/Isis appear in Neon as Modules and can only be started from within Neon.
All Ikaros, Isis, and Metafer version prior to those named above are not compatible with
Neon and can be executed independent from each other.
Neon
Intended Use
Neon is MetaSystems' platform for case and image data organization, for all MetaSystems
devices. MetaSystems solutions are designed to address particular imaging and image anal-
ysis tasks. Neon collects the data from any imaging job, and from external sources, and
presents them in comprehensive and versatile case management dashboard. Hence, Neon
always has the most relevant information for the user at hand; fast and secure, regardless
of where the information originates. Strong data management algorithms, several conven-
ient display modes, and many options for selecting and filtering content make Neon the
perfect basis to organize large quantities of heterogeneous information. Neon does not
provide any in vitro diagnostic function by itself but is an accessory for the imaging plat-
forms Ikaros, Isis and Metafer.
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 (IVD) de-
vices:
EU
Australia
Brazil
Canada
Japan
U.S.A
Neon
)
*
Class 1 / TGA
ARTG inclusion
Anvisa
DOU entry
MAH License no.
13B3X10527
Class 1 / Listing
* 98/79/EC IVD directive