Fusion Bx - Fusion Bx 2.0 is designed to display the 2D live - Focal Healthcare Inc

Duns Number:200507997

Device Description: Fusion Bx 2.0 is designed to display the 2D live video received from commercially availabl Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.

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More Product Details

Catalog Number

-

Brand Name

Fusion Bx

Version/Model Number

2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

851ab1f4-b6a9-4c00-bd99-cac7664ae0a9

Public Version Date

July 12, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

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