METRITRACK, INC.

Address:8190 BEECHMONT AVE.,CINCINNATI,OH,45255,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1)

Premarket Exempt

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Breast Volume Navigation (BVN) - 08636860003008 Catalog Number : 000266

Device Description : The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound 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.

Device Class : 2

Duns Number: 009329627

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

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