Fusion Bx

GUDID 00628055858003

Fusion Bx 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. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer. Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. Encoders in the stepper and tracker send joint movement information to the computer workstation which tracks probe position and orientation. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Fusion Bx. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate and to display the live image position within the prostate.

Focal Healthcare Inc

Radiology picture archiving and communication system workstation

• Primary Device ID: 00628055858003
• NIH Device Record Key: 12d2030d-e6ed-44c1-90c4-106056a3a78b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Bx
• Version Model Number: 1.1
• 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	00628055858003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153166

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: 5
• Public Version Date: 2021-07-12
• Device Publish Date: 2016-10-01

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