iScan 700-49428-002

GUDID 00858848006315

iVue 500 System

OPTOVUE, INC.

Spectral-domain optical coherence tomography system

• Primary Device ID: 00858848006315
• NIH Device Record Key: ae4f9653-8971-4cdd-9e5e-41b73454f1ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iScan
• Version Model Number: iVue 500
• Catalog Number: 700-49428-002
• Company DUNS: 196500461
• Company Name: OPTOVUE, 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: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 866-941-9240
• Email: service@optovue.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858848006315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133892

FDA Product Code

• HLI: Ophthalmoscope, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [iScan]

• 00858848006438: Ophthalmic Optical Coherence Tomography System
• 00858848006421: Ophthalmic Optical Coherence Tomography System
• 00858848006407: Ophthalmic Optical Coherence Tomography System
• 00858848006315: iVue 500 System
• 00858848006018: iVue 500 System
• 00858848006742: Ophthalmic Optical Coherence Tomography System
• 00858848006735: Ophthalmic Optical Coherence Tomography System