IMAGEnet 6 OPHTHALMIC DATA SYSTEM

GUDID 04562123288582

TOPCON CORPORATION

Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Camera application software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS 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

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• 04560126266071 - KR-1W Viewer: 2022-09-08
• 04562123280531 - PRISM COMPENSATOR for LENSMETER LM-8: 2022-09-08
• 04562123286441 - TL-5A: 2022-09-08
• 04562123286465 - OBLIQUE ILLUMINATOR MS-OI04: 2022-09-08