Digital slide scanner

The NanoZoomer Series is a family of whole slide scanners that convert glass slides into high-resolution digital data by high-speed scanning.
The NanoZoomer comes with a variety of functions such as image acquisition of fluorescence samples and multilayer acquisition. Scanned data can be viewed on a PC monitor by using the dedicated viewer software, and patented navigation map technique* delivers slide viewing environment just as if operating a microscope.

NanoZoomer S20 Digital Slide Scanner for Digital Pathology

NanoZoomer product range and its possibility

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 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 NanoZoome 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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