Synergy ODM

GUDID 00850003069081

Synergy ODM 4.09.500 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

TOPCON HEALTHCARE SOLUTIONS, INC.

Camera application software

• Primary Device ID: 00850003069081
• NIH Device Record Key: 4abf0480-1488-44f3-8ec2-35cd8ba001c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy ODM
• Version Model Number: 4.09.500
• 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	00850003069081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151952

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: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [Synergy ODM]

• 00850003069081: Synergy ODM 4.09.500 is a comprehensive software platform intended for use in importing, process
• 00850003069036: Synergy ODM 4.10.500 is a comprehensive software platform intended for use in importing, process