Fusion Bx

GUDID 00628055858010

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.

Focal Healthcare Inc

Radiology picture archiving and communication system workstation

• Primary Device ID: 00628055858010
• NIH Device Record Key: 851ab1f4-b6a9-4c00-bd99-cac7664ae0a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Bx
• Version Model Number: 2.0
• Company DUNS: 200507997
• Company Name: Focal Healthcare Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055858010 [Primary]
GS1	26280558580027 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-01
• Device Publish Date: 2018-08-31

On-Brand Devices [Fusion Bx]

• 16280558580020: Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultr
• 26280558580010: Fusion Bx is designed to display the 2D live video received from commercially available ultrasou
• 00628055858010: Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultr
• 00628055858003: Fusion Bx is designed to display the 2D live video received from commercially available ultrasou