Breast Volume Navigation (BVN) - The Breast Volume Navigator (BVN) is an add-on - METRITRACK, INC.

Duns Number:009329627

Device Description: The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging s 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 will allow exporting to any third party application that has the appropriate level of DICOM compliance.The BVN is intended as a general purpose digital 3D breast ultrasound image processing tool for radiology and surgery.The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.The device is not intended to be used as a replacement for screening mammography.

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More Product Details

Catalog Number

000266

Brand Name

Breast Volume Navigation (BVN)

Version/Model Number

G-1000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Device Record Status

Public Device Record Key

9370aabf-716c-4ea3-98a3-f7d317bab90f

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

May 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"METRITRACK, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1