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Breast Volume Navigator (BVN)

FDA UDI

Class II (US FDA UDI)

by Metritrack, Inc.

Identity

Trade Name
Breast Volume Navigator (BVN) FDA UDI
Generic Name
Breast ultrasound imaging system FDA UDI
Device Name
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. FDA UDI
Model / Reference
G-2000 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
000600 FDA UDI
Primary DI / UDI-DI
00863686000302 FDA UDI
510(k) Number
K211098 FDA UDI
FDA Product Code
LLZ FDA UDI
IYO FDA UDI
GMDN Term
Breast ultrasound imaging system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
892.1560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breast ultrasound imaging system

Breast Volume Navigator (BVN) by Metritrack, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breast ultrasound imaging system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Metritrack, Inc.

Sources (1)

  • FDA UDI 9370aabf-716c-4ea3-98a3-f7d317bab90f 36 fields · synced Jun 8, 2026