Breast Volume Navigator (BVN) 000600

GUDID 08636860003008

The Breast Volume Navigator (BVN™) is an add-on accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2-dimensional image slices throughout a volume of interest. The BVN™ is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The BVN™ is intended to assist health care providers trained in breast ultrasound with tools for electromagnetic tracking of instruments with respect of breast ultrasound images generated from FDA cleared hand-held ultrasound devices. The BVN™ is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with a linear array transducer. The BVN™ is indicated for use as an adjunct to hand-held breast ultrasound to assist the health care providers trained in breast ultrasound in their scanning process. The scanning paths are displayed on a route map and provide quality control of scanning to provide an overall observation of scanning process.

METRITRACK, INC.

Breast ultrasound imaging system

• Primary Device ID: 08636860003008
• NIH Device Record Key: 9370aabf-716c-4ea3-98a3-f7d317bab90f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breast Volume Navigator (BVN)
• Version Model Number: G-2000
• Catalog Number: 000600
• Company DUNS: 009329627
• Company Name: METRITRACK, 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com
• Phone: 1-708-498-3578
• Email: office@metritrack.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08636860003008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211098

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-02-15
• Device Publish Date: 2017-05-01

On-Brand Devices [Breast Volume Navigator (BVN)]

• 08636860003008: The Breast Volume Navigator (BVN™) is an add-on accessory for existing ultrasound imaging syst
• 00863686000302: The Breast Volume Navigator (BVN™) is an add-on accessory for existing ultrasound imaging syst