VivoSight

GUDID 05060507260012

The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated

MICHELSON DIAGNOSTICS LTD

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• Primary Device ID: 05060507260012
• NIH Device Record Key: 4706958b-a7c7-4eaa-bd4b-3e4d63a11c01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivoSight
• Version Model Number: VivoSight Dx
• Company DUNS: 349363346
• Company Name: MICHELSON DIAGNOSTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	05060507260012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153283

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

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: 2016-11-14

On-Brand Devices [VivoSight]

• 05060507260012: The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging
• 05060507260005: The VivoSight Topical OCT system is indicated for use in the two-dimensional, cross-sectional, r