DEVICE: NanoZoomer S360MD Slide scanner system (04582389010659)

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Device Record History
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Device Identifier (DI) Information
NanoZoomer S360MD Slide scanner system
C13220-01MD
In Commercial Distribution

HAMAMATSU PHOTONICS K.K.
04582389010659
GS1

1
704524537 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62575 Microscope slide digital imaging scanner IVD
A mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.
Active false
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FDA Product Code

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Product Code Product Code Name
PSY Whole Slide Imaging System
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K213883 000
K233027 000
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Sterilization
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
01d9c2d3-5dd3-4461-a5a5-3cde4fcfe989
January 09, 2024
2
October 01, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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No Customer Contact currently defined
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