Why NanoZoomer

Why NanoZoomer

Discover why our range of whole slide scanners are the perfect fit for any solution.

Solutions

Solutions

Discover how NanoZoomers could be integrated into your workflow for optimal efficiencies.

Products

Discover our NanoZoomer series: Creating high resolution digital images from glass slides by high speed scanning.

Case studies

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NanoZoomer® product range and its possibility

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.

C13220-01 NanoZoomer S360 Digital slide scanner is not sold as the IVDD unit to EU region after May 27th in 2022.

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