IMAGEnet 6

GUDID 00850003069050

The IMAGEnet 6 ver. 2.0.3 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.

Camera application software

• Primary Device ID: 00850003069050
• NIH Device Record Key: 8b665fc2-fb17-47e2-a8fe-eb2377caa0f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGEnet 6
• Version Model Number: 2.0.3
• 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	00850003069050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171370

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-02-14

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