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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
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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 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 | 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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