NanoZoomer S540 Digital slide scanner C17400-01

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.

Important Notice

In the USA, the NanoZoomer S360MD Slide scanner system(C13220-01MD) 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), UK MDR2002 (UK) and IvDO (CH) for in vitro diagnostic use:
NanoZoomer S360MD Slide scanner system(C13220-21MDEU), NanoZoomer S60v2MD Slide scanner system(C16600-21MDEU), NanoZoomer S20MD Slide scanner system(C16300-21MDEU) and NanoZoomer S540MD Slide scanner system(C17400-21MDEU).

In China, the following products are registered for in vitro diagnostic use:
NanoZoomer S360 Digital slide scanner(C13220-01) and NanoZoomer S60 Digital slide scanner(C13210-01).

In Canada, NanoZoomer S360 Digital slide scanner(C13220-31), NanoZoomer S540MD Slide scanner system(C17400-00MD) and NanoZoomer S20MD Slide scanner system(C16300-31MDCA) have Medical Device License.

In Taiwan, NanoZoomer S360 Digital slide scanner(C13220-01) is registered as medical device.

In Korea, NanoZoomer S360MD Slide scanner system(C13220-61MDK) and NanoZoomer S20MD Slide scanner system(C16300-61MDK) are registered as in vitro diagnostic medical device.

In Japan, NanoZoomer S360MD Slide scanner system(C13220-11MDJ) and NanoZoomer S20MD Slide scanner system(C16300-11MDJ) are approved as medical devices.

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

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

In India, NanoZoomer S360MD Slide scanner system(C13220-71MD) and NanoZoomer S20MD Slide scanner system(C16300-71MD) have Medical Device License.

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

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