Harmony

GUDID 00850003069517

Harmony 5.09 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 INC

Camera application software

• Primary Device ID: 00850003069517
• NIH Device Record Key: 6e6759f9-e401-4ea6-82e1-94dd48c5dfaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony
• Version Model Number: 5.09
• Company DUNS: 053547238
• Company Name: TOPCON HEALTHCARE 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	00850003069517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182376

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: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [Harmony]

• 00850003069593: Harmony 6.2 is a comprehensive software platform intended for use in importing, processing, meas
• 00850003069586: Harmony 6.1.1 is a comprehensive software platform intended for use in importing, processing, me
• 00850003069579: Harmony 6.1 is a comprehensive software platform intended for use in importing, processing, meas
• 00850003069562: Harmony 5.09.004 is a comprehensive software platform intended for use in importing, processing,
• 00850003069555: Harmony 5.09.003 is a comprehensive software platform intended for use in importing, processing,
• 00850003069548: Harmony 5.09.002 is a comprehensive software platform intended for use in importing, processing,
• 00850003069531: Harmony 6.0 is a comprehensive software platform intended for use in importing, processing, meas
• 00850003069524: Harmony 5.09.001 is a comprehensive software platform intended for use in importing, processing,
• 00850003069517: Harmony 5.09 is a comprehensive software platform intended for use in importing, processing, mea
• 00850003069500: Harmony 5.08.001 is a comprehensive software platform intended for use in importing, processing,
• 00850003069432: Harmony 5.08 is a comprehensive software platform intended for use in importing, processing, mea
• 00850003069357: Harmony 5.07.004 is a comprehensive software platform intended for use in importing, processing,