IDx-DR

GUDID 00860005195619

Digital Diagnostics Inc.

Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Automated retinopathy analysis system application software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software

• Primary Device ID: 00860005195619
• NIH Device Record Key: 64501863-533c-4c61-a690-93e53af716ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDx-DR
• Version Model Number: V2
• Company DUNS: 028582271
• Company Name: Digital Diagnostics 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005195619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203629

FDA Product Code

• PIB: Diabetic Retinopathy Detection Device

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: 2021-07-19
• Device Publish Date: 2021-07-09

On-Brand Devices [IDx-DR]

• 00860005195619: V2
• 00860005195626: v2.3