NanoZoomer S360MD Slide scanner system

GUDID 04582389010659

HAMAMATSU PHOTONICS K.K.

Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD

• Primary Device ID: 04582389010659
• NIH Device Record Key: 01d9c2d3-5dd3-4461-a5a5-3cde4fcfe989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoZoomer S360MD Slide scanner system
• Version Model Number: C13220-01MD
• Company DUNS: 704524537
• Company Name: HAMAMATSU PHOTONICS K.K.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582389010659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213883

FDA Product Code

• PSY: Whole Slide Imaging System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-10
• Device Publish Date: 2022-10-01

Devices Manufactured by HAMAMATSU PHOTONICS K.K.

• 04582389010871 - PDE-GEN3: 2023-06-09
• 04582389010659 - NanoZoomer S360MD Slide scanner system: 2022-10-10
• 04582389010659 - NanoZoomer S360MD Slide scanner system: 2022-10-10
• 04582389010031 - PDE: 2018-07-06
• 04582389010062 - NIRO-200NX: 2018-07-06
• 04582389010093 - pde-neo: 2018-07-06
• 04582389010543 - pde-neoII: 2018-07-06