Sonalleve 451000080796

GUDID 07540281000267

SONALLEVE MR-HIFU V2 INGENIA 3T

Profound Medical Inc

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 07540281000267
• NIH Device Record Key: f90364b2-2f85-472f-a636-452031efdec9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonalleve
• Version Model Number: 451000080796
• Catalog Number: 451000080796
• Company DUNS: 243898678
• Company Name: Profound Medical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	07540281000267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H190003

FDA Product Code

• QND: Ablation System, High Intensity Focused Ultrasound (Hifu), Mr Guided, Orthopedic

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: 2025-08-14
• Device Publish Date: 2025-08-06

On-Brand Devices [Sonalleve]

• 07540281000267: SONALLEVE MR-HIFU V2 INGENIA 3T
• 07540281000250: SONALLEVE MR-HIFU V2 INGENIA 1.5T
• 07540281000243: SONALLEVE MR-HIFU V2 ACHIEVA 3T
• 07540281000236: SONALLEVE MR-HIFU V2 ACHIEVA 1.5T