Visualize:Vascular INITVV

GUDID B725INITVV1

Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.

SALIENT IMAGING

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• Primary Device ID: B725INITVV1
• NIH Device Record Key: a47ca54e-2a3d-4f6d-bf20-2c540b983746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visualize:Vascular
• Version Model Number: 1.2
• Catalog Number: INITVV
• Company DUNS: 046672032
• Company Name: SALIENT IMAGING
• Device Count: 3
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com
• Phone: 16033154952
• Email: jsterritt@salientimaging.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B725INITVV1 [Unit of Use]
HIBCC	B725INITVV12 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103761

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-06-14
• Device Publish Date: 2021-06-04