Harmony

GUDID 00850003069289

Harmony 5.06.002 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: 00850003069289
• NIH Device Record Key: 44032cfb-52c7-404d-8cd2-078018347312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony
• Version Model Number: 5.06.002
• 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	00850003069289 [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: 2021-02-12
• Device Publish Date: 2021-02-04

On-Brand Devices [Harmony]

• 00850003069043: Harmony 5.04 is a comprehensive software platform intended for use in importing, processing, mea
• 00850003069098: Harmony 5.03.200 is a comprehensive software platform intended for use in importing, processing,
• 00850003069012: Harmony 5.03 is a comprehensive software platform intended for use in importing, processing, mea
• 00850003069173: Harmony 5.04.100 is a comprehensive software platform intended for use in importing, processing,
• 00850003069180: Harmony 5.04.200 is a comprehensive software platform intended for use in importing, processing,
• 00850003069111: Harmony 5.05 is a comprehensive software platform intended for use in importing, processing, mea
• 00850003069197: Harmony 5.05.100 is a comprehensive software platform intended for use in importing, processing,
• 00850003069227: Harmony 5.05.101 is a comprehensive software platform intended for use in importing, processing,
• 00850003069234: Harmony 5.05.102 is a comprehensive software platform intended for use in importing, processing,
• 00850003069128: Harmony 5.06 is a comprehensive software platform intended for use in importing, processing, mea
• 00850003069289: Harmony 5.06.002 is a comprehensive software platform intended for use in importing, processing,
• 00850003069296: Harmony 5.06.003 is a comprehensive software platform intended for use in importing, processing,
• 00850003069265: Harmony 5.07 is a comprehensive software platform intended for use in importing, processing, mea