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 Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system 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