Focalyx Fusion

GUDID 00860003552001

The Focalyx Fusion system is designed for the fusion/registration of MRI and transrectal ultrasound (TRUS) images of the prostate during a transperineal biopsy or therapy procedure. The software supports computer-assisted surgical planning and provides a tool for real-time surgical guidance by reproducing and supplementing the visual information provided by real-time ultrasound imaging. The intended use of the system is to superimpose a graphical representation of one or more surgical targets on to real-time US images of the prostate to aid targeted needle guidance in the diagnosis or treatment of prostate cancer. The system is to be used by qualified physicians who are familiar with the safe operation of transrectal ultrasound and positioning devices during medical procedures involving the prostate. There are no known contraindications for the use of the device.

Focalyx Technologies, LLC

Ultrasound imaging system application software

• Primary Device ID: 00860003552001
• NIH Device Record Key: e17c969e-b2e6-4da2-8f66-97f8a4d41c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focalyx Fusion
• Version Model Number: 1.7
• Company DUNS: 117674092
• Company Name: Focalyx Technologies, LLC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com
• Phone: 1-888-636-2259
• Email: support@focalyxtechnologies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003552001 [Primary]

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: 2026-01-12
• Device Publish Date: 2026-01-02