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ProductsNanoZoomer line-up
ProductNanoZoomer S20MD Slide scanner system
ProductNanoZoomer S60v2MD Slide scanner system
ProductNanoZoomer S360MD Slide scanner system
NanoZoomer slide scanner systems for medical use
Committed to the digital pathology market for over 18 years, Hamamatsu Photonics is known for our market-leading photonics technology. We integrate our knowhow into the NanoZoomer whole slide scanners, providing a stamp of reliability.
Your Lab, Your Way
“Your lab, your way” means you choose which NanoZoomer digital scanners fit your workflow needs. Benefit from each scanners’ unique features providing you the flexibility to decide what works best and when. A family of whole slide imaging scanners produce high-resolution digital images from glass slides by high-speed scanning. Digital images can be viewed across networks to support remote diagnostic workflow by using the dedicated viewer software. The image acquisition software (NZAcquireMD) and the image viewing software (NZViewMD) allow users to easily create, view and perform quality-checks on whole slide images.
NanoZoomer line-up
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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 S60v2 | 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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