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Slide scanner system for medical
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The matrix shows the NanoZoomer IVD series offered by region. The NanoZoomer IVD series is registered as a medical device in accordance with legal requirements.
| USA | EU/EEA | UK | Swizerland | China | Canada | Taiwan | Republic of Korea | Japan | Türkiye | Israel | India | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NanoZoomer S20MD | C16300-21MDEU | C16300-21MDEU | C16300-21MDEU | C16300-31MDCA | C16300-61MDK | C16300-11MDJ | C16300-21MDEU | C16300-71MD | ||||
| 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 | C13220-71MD | |||
| NanoZoomer S540MD | C17400-21MDEU | C17400-21MDEU | C17400-21MDEU | C17400-00MD | C17400-21MDEU | C17400-21MDEU | ||||||
| NanoZoomer S60 | C13210-01 | |||||||||||
| NanoZoomer S360 | C13220-01 | C13220-31 | C13220-01 |
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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