Whole Slide Imaging - WSI
This chart shows the NanoZoomer series registered as medical systems in each country.
In countries except for the described ones in this sheet, the NanoZoomer series are used for "Research Use Only(RUO)".
In the USA, C13220-01MD NanoZoomer S360MD Slide scanner system is intended for in vitro diagnostic use.
In Europe, following products are regulatory compliant for IVDR (EU), UKCA (UK) and IvDO (CH) for in vitro diagnostic use:
C13220-21MDEU NanoZoomer S360MD Slide scanner system, C16600-21MDEU NanoZoomer S60v2MD Slide scanner system and C16300-21MDEU NanoZoomer S20MD Slide scanner system.
In China, following products are registered for in vitro diagnostic use:
C13220-01 NanoZoomer S360, C13239-01 NanoZoomer S210, C13210-01 NanoZoomer S60 and C13140-01 NanoZoomer-SQ.
In Canada, C13220-31 NanoZoomer S360 has Medical Device License.
In Taiwan, C13220-01 NanoZoomer S360 is registered as medical device.
In Korea, C13220-61MDK NanoZoomer S360MD Slide scanner system is registered as in vitro diagnostic medical device.
In Japan, C13220-11MDJ Slide scanner system is approved as medical device.
For other countries, NanoZoomer series are for research use only and not permitted to use for clinical diagnostic purpose.
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