ProFuse 900-07000-00

GUDID 00860009734807

MRI annotation and analysis tool

Eigen Health Services LLC

Rectal ultrasound navigational image processor

• Primary Device ID: 00860009734807
• NIH Device Record Key: f1126583-4883-4e19-8fc9-378ff9c02bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFuse
• Version Model Number: 1.0
• Catalog Number: 900-07000-00
• Company DUNS: 117062155
• Company Name: Eigen Health Services LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009734807 [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: 2026-02-05
• Device Publish Date: 2026-01-28

Devices Manufactured by Eigen Health Services LLC

• 00860009734807 - ProFuse: 2026-02-05MRI annotation and analysis tool
• 00860009734807 - ProFuse: 2026-02-05 MRI annotation and analysis tool
• 00860009734814 - Artemis: 2026-02-05 3D workstation for Transrectal/transperineal biopsy navigation and planning of the prostate.
• 00860009734821 - Artemis-TPOS: 2026-02-05 3D workstation for transperineal only biopsy navigation and planning of the prostate.
• 00860009734838 - Artemis with ProFuse: 2024-12-30 Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostat