Breast Volume Navigator (BVN)
Basic Information
- Brand Name
- Breast Volume Navigator (BVN)
- Primary DI
- 00863686000302
- Version / Model
- G-2000
- Catalog Number
- 000600
- Company Name
- Metritrack, Inc.
- Labeler DUNS
- 009329627
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-01
- Public Version
- 8
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 9370aabf-716c-4ea3-98a3-f7d317bab90f
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40764 | Breast ultrasound imaging system | An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00863686000302 | GS1 |
Customer Contacts
- Phone
- 1-708-498-3578
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211098 | 000 |