NanoZoomer S360 Digital slide scanner
The NanoZoomer series is a family of whole slide scanners that rapidly scan glass slides to convert them to digital data.
The NanoZoomer S360 is the latest high-throughput model, ideal for use in hospitals and clinical laboratories.
C13220-01 is a medical system in China and Taiwan. This is for RUO in other countries.
C13220-01 NanoZoomer S360 Digital slide scanner is not sold as the IVDD unit to EU region after May 27th in 2022.
Product name | NanoZoomer S360 |
---|---|
Product number | C13220-01 |
Scanning speeds: 20× mode (15 mm × 15 mm) | Approx. 30 s |
Scanning speeds: 40× mode (15 mm × 15 mm) | Approx. 30 s |
Throughput: 20× mode (15 mm × 15 mm) | More than 82 slides/h *1 |
Throughput: 40× mode (15 mm × 15 mm) | More than 82 slides/h *1 |
Objective lens | 20× (NA 0.75) User can select 20× or 40× mode at start of scanning. |
Compatible glass slide | 26 mm × 76 mm Thickness 0.9 mm to 1.2 mm |
Slide loader (standard size slide) | 360 slides (30 slides × 12 cassettes) |
Scanning resolution: 20× mode | 0.46 μm/pixel |
Scanning resolution: 40× mode | 0.23 μm/pixel |
Focusing method | Pre-focus map |
Z-stack feature | Included |
Fluorescence imaging module | No |
Barcode reader | 1D barcode (standard feature), 2D barcode (option) |
Slide format | JPEG compressed image + slide information |
Power supply | AC100 V to AC240 V |
Power consumption (scanner only) | Approx. 200 VA |
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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