CADENCE

GUDID B857000

Camera, Ophthalmic, ac-powered

Retina-Ai Health, Inc.

Ophthalmic fundus camera

• Primary Device ID: B857000
• NIH Device Record Key: f659a4d5-8ba2-4f25-8e41-c73621d100b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CADENCE
• Version Model Number: 100
• Company DUNS: 117424067
• Company Name: Retina-Ai Health, 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
HIBCC	B857000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182199

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2020-03-03
• Device Publish Date: 2020-02-24