FDA UDI
In Commercial Distribution
🇺🇸 United States
Sonalleve
DI: 07540281000243
·
Model: 451000080776
·
Profound Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sonalleve
- Primary DI
- 07540281000243
- Version / Model
- 451000080776
- Catalog Number
- 451000080776
- Company Name
- Profound Medical Inc
- Labeler DUNS
- 243898678
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-06
- Public Version
- 1
- Public Version Date
- 2025-08-14
- Public Version Status
- New
- Public Device Record Key
- ba08b895-14a6-4779-8e8a-299a36fbd2a2
Device Description
SONALLEVE MR-HIFU V2 ACHIEVA 3T
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QND | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr Guided, Orthopedic |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57888 | Therapeutic oncological/gynaecological ultrasound system | An assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. It typically consists of a piezoelectric transducer (probe), a water supply/power control unit, operator console and monitoring systems, software, and sometimes a patient table. Optimal patient positioning is achieved using an ultrasound scanner or MRI system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540281000243 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H190003 | 000 |