Fusion Bx

GUDID 16280558580020

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

Focal Healthcare Inc

Radiology picture archiving and communication system workstation

• Primary Device ID: 16280558580020
• 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	16280558580020 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• 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