Neurolyser XR

GUDID 07290019747000

The Neurolyser XR is intended for thermal ablation of neural tissue (neurolysis) at the bone tissue interface, using non- invasive high intensity focused ultrasound (HIFU) with X-ray guidance.

FUSMobile LTD

Nerve transcutaneous ultrasound ablation system

• Primary Device ID: 07290019747000
• NIH Device Record Key: c804ac2a-116a-42ed-9c8f-0e9b48abb706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurolyser XR
• Version Model Number: NXR100
• Company DUNS: 531885190
• Company Name: FUSMobile LTD
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019747000 [Primary]
GS1	17290019747007 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN250015

FDA Product Code

• SGN: High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

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: 2025-12-18
• Device Publish Date: 2025-12-10

Devices Manufactured by FUSMobile LTD

• 07290019747000 - Neurolyser XR: 2025-12-18The Neurolyser XR is intended for thermal ablation of neural tissue (neurolysis) at the bone tissue interface, using non- invasive high intensity focused ultrasound (HIFU) with X-ray guidance.
• 07290019747000 - Neurolyser XR: 2025-12-18 The Neurolyser XR is intended for thermal ablation of neural tissue (neurolysis) at the bone tissue interface, using non- invasi
• 07290019747017 - Neurolyser XR 30 mm Gel Pad: 2025-12-18
• 07290019747024 - Neurolyser XR 45 mm Gel Pad: 2025-12-18
• 17290019747038 - Neurolyser XR DQA Assembly: 2025-12-18