NanoZoomer S360MD Slide scanner system

GUDID 04582389010659

HAMAMATSU PHOTONICS K.K.

Microscope slide digital imaging scanner IVD
Primary Device ID04582389010659
NIH Device Record Key01d9c2d3-5dd3-4461-a5a5-3cde4fcfe989
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoZoomer S360MD Slide scanner system
Version Model NumberC13220-01MD
Company DUNS704524537
Company NameHAMAMATSU PHOTONICS K.K.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582389010659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSYWhole Slide Imaging System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-10
Device Publish Date2022-10-01

Devices Manufactured by HAMAMATSU PHOTONICS K.K.

04582389010871 - PDE-GEN32023-06-09
04582389010659 - NanoZoomer S360MD Slide scanner system2022-10-10
04582389010659 - NanoZoomer S360MD Slide scanner system2022-10-10
04582389010031 - PDE2018-07-06
04582389010062 - NIRO-200NX2018-07-06
04582389010093 - pde-neo2018-07-06
04582389010543 - pde-neoII2018-07-06

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