IMAGEnet 6 OPHTHALMIC DATA SYSTEM

GUDID 04562123288582

TOPCON CORPORATION

Camera application software

• Primary Device ID: 04562123288582
• NIH Device Record Key: f00e9ec8-aad8-4bfc-9120-ce866193e983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGEnet 6 OPHTHALMIC DATA SYSTEM
• Version Model Number: IMAGEnet 6
• Company DUNS: 690542881
• Company Name: TOPCON CORPORATION
• 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: true
• Serial Number: true
• 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	04562123288582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171370

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-27
• Device Publish Date: 2018-02-07

Devices Manufactured by TOPCON CORPORATION

• 04560126268495 - SightPilot NAVi Contoller SNi-1 for COMPU VISION CV-5000: 2025-03-07
• 04560126268532 - COMPU VISION CV-5000: 2025-03-07
• 04560126268549 - COMPU VISION CV-5000: 2025-03-07
• 04560126268570 - 1DIAL CONTROLLER KB-50S: 2025-03-07
• 04560126268624 - POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE): 2025-03-07
• 04560126268648 - POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE): 2025-03-07
• 04571130282773 - REFRACTION SYSTEM Chronos: 2024-08-09
• 04571130283350 - AUTO KERATO-REFRACTOMETER KR-800: 2024-05-17