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This chart shows the NanoZoomer series registered as medical systems in each country.

USA China Taiwan EU
C13220-01MD C13220-01 C13220-01 C13220-21MDEU
  C13239-01   C16600-21MDEU
  C13210-01   C16300-21MDEU
  C13140-01    

In countries except for the described ones in this sheet, the NanoZoomer series are used for "Research Use Only(RUO)".

For research use, please click here.

Important Notice

In the USA, C13220-01MD NanoZoomer S360MD Slide scanner system can be used for primary diagnosis in the following validated FDA-cleared displays:

・JVC JD-C240BN01A      *The display is FDA cleared for use with the NanoZoomer S360MD.

・BARCO MDPC-8127      *The display itself is FDA cleared.

 

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 NanoZoomer S360MD Slide scanner system and C16300-11MDJ NanoZoomer S20MD Slide scanner system are approved as medical devices.

 

For other countries, NanoZoomer series are for research use only and not permitted to use for clinical diagnostic purpose.

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