SCANLY 910-0001

GUDID 07290017803012

Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device

NOTAL VISION LTD

Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system Retinal optical coherence tomography system

• Primary Device ID: 07290017803012
• NIH Device Record Key: b1a36a14-5825-4b2e-a6cd-4879b5203dab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLY
• Version Model Number: 01.01
• Catalog Number: 910-0001
• Company DUNS: 532596533
• Company Name: NOTAL VISION LTD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017803012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN230043

FDA Product Code

• SAX: Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging 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: 2024-06-26
• Device Publish Date: 2024-06-18

Devices Manufactured by NOTAL VISION LTD

• 07290017803012 - SCANLY: 2024-06-26Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device
• 07290017803012 - SCANLY: 2024-06-26 Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device
• 07290017803005 - Foresee Home™: 2021-04-09