IMAGEnet 6

GUDID 00850003069302

The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.

TOPCON HEALTHCARE SOLUTIONS, INC.

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• Primary Device ID: 00850003069302
• NIH Device Record Key: 649cb140-0a74-4424-8b34-ebf5e75e01cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGEnet 6
• Version Model Number: 2.4.0
• Company DUNS: 081155097
• Company Name: TOPCON HEALTHCARE SOLUTIONS, INC.
• 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: false
• Manufacturing Date: false
• 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	00850003069302 [Primary]

FDA Product Code

• OBO: Tomography, Optical Coherence

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: 2020-12-17
• Device Publish Date: 2020-12-09

On-Brand Devices [IMAGEnet 6]

• 00850003069050: The IMAGEnet 6 ver. 2.0.3 is a software program that is intended for use in the collection, stor
• 00850003069029: The IMAGEnet 6 ver. 2.0.2 is a software program that is intended for use in the collection, stor
• 00850003069005: The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the collection, storag
• 00850003069074: The IMAGEnet 6 ver. 2.1.0 is a software program that is intended for use in the collection, stor
• 00850003069142: The IMAGEnet 6 ver. 2.1.1 is a software program that is intended for use in the collection, stor
• 00850003069203: The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection, stor
• 00850003069166: The IMAGEnet 6 ver. 2.2.0 is a software program that is intended for use in the collection, stor
• 00850003069241: The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the collection, stor
• 00850003069302: The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, stor