Glaucoma Module

GUDID 00850003069135

Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coherence tomography data.

TOPCON HEALTHCARE SOLUTIONS, INC.

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• Primary Device ID: 00850003069135
• NIH Device Record Key: cb65653e-24e0-4531-8f37-cbc1d695de49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glaucoma Module
• Version Model Number: 1.00
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003069135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200954

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

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: 2021-03-08
• Device Publish Date: 2021-02-26

Devices Manufactured by TOPCON HEALTHCARE SOLUTIONS, INC.

• 00850003069135 - Glaucoma Module: 2021-03-08Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coherence tomography data.
• 00850003069135 - Glaucoma Module: 2021-03-08 Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coh
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• 00850003069289 - Harmony: 2021-02-12 Harmony 5.06.002 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and stora
• 00850003069128 - Harmony: 2021-02-08 Harmony 5.06 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage o
• 00850003069234 - Harmony: 2021-02-03 Harmony 5.05.102 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and stora
• 00850003069227 - Harmony: 2021-01-27 Harmony 5.05.101 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and stora
• 00850003069197 - Harmony: 2021-01-22 Harmony 5.05.100 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and stora