NanoZoomer® S360MD Slide scanner system

C13220-01MD

NanoZoomer S360MD Slide scanner system is an automated digital slide creation, viewing, and management system.

 

This system is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded ("FFPE") tissue.

 

NanoZoomer is a registered trademark of Hamamatsu Photonics K.K. (EU, Japan, UK, USA).

Intended Use

The NanoZoomer S360MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. The NanoZoomer System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (“FFPE”) tissue. The NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. 

 

The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and a compatible display that has been 510(k) cleared for use with the NanoZoomer system or a 510(k)-cleared display that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional compatible displays. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using NanoZoomer System.     

Features

Product movie

Gallery

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Specifications

Product name NanoZoomer S360MD Slide scanner system
Product number C13220-21MD
Scanning speed: 20× mode (15 mm × 15 mm) Approx. 30 s
Scanning speed: 40× mode (15 mm × 15 mm) Approx. 30 s
Throughput: 20× mode (15 mm × 15 mm) 82 slides/h *1
Throughput: 40× mode (15 mm × 15 mm) 82 slides/h *1
Objective lens 20× NA 0.75
User can select 20× or 40× mode at start of scanning.
Compatible glass slides 25.0 mm to 26.0 mm × 75.0 mm to 76.0 mm
(Thickness 0.9 mm to 1.2 mm)
Slide loader (standard size slide) 360 slides (30 slides × 12 cassettes)
Scanning resolution: 20× mode Approx. 0.46 μm/pixel
Scanning resolution: 40× mode Approx. 0.23 μm/pixel
Focusing method Pre-focus map
Z-stack feature Included
Image compression JPEG compression
Readable barcodes: 1D Barcodes Code 39, Code 128, Interleaved 2 of 5, Codabar, EAN-8 and UPC-E
Readable barcodes: 2D Barcodes DataMatrix (ECC200)
Power supply AC 100 V to AC 240 V
Power consumption (scanner only) Approx. 200 VA

*1 When it scans an area of 15 mm  × 15 mm square with 5 focus points.

Dimensions

Important Notice

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 S60         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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