Slide scanner system for medical

The matrix sheet shows the NanoZoomer IVD series registered as medical system in each region.

USA EU/EEA UK Swizerland China Canada Taiwan Republic of Korea Japan Turkey Israel
NanoZoomer S20MD   C16300-21MDEU C16300-21MDEU C16300-21MDEU   C16300-31MDCA     C16300-11MDJ C16300-21MDEU  
NanoZoomer S60v2MD   C16600-21MDEU C16600-21MDEU C16600-21MDEU           C16600-21MDEU C16600-21MDEU
NanoZoomer S360MD C13220-01MD C13220-21MDEU C13220-21MDEU C13220-21MDEU       C13220-61MDK C13220-11MDJ C13220-21MDEU C13220-21MDEU
NanoZoomer S60         C13210-01            
NanoZoomer S360         C13220-01 C13220-31 C13220-01        
NanoZoomer S210         C13239-01            
NanoZoomer-SQ                      

Important Notice

In the USA, the 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, the 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, the 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 and C16300-31MDCA NanoZoomer S20MD Slide scanner system have 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.

In Turkey, C13220-21MDEU NanoZoomer S360MD Slide scanner system, C16600-21MDEU NanoZoomer S60v2MD Slide scanner system and C16300-21MDEU NanoZoomer S20MD Slide scanner system are registered as medical devices.

In Israel, C13220-21MDEU NanoZoomer S360MD Slide scanner system and C16600-21MDEU NanoZoomer S60v2MD Slide scanner system are registered as medical devices.

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

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