High Intensity Focused Ultrasound System
Basic Information
- Primary DI
- 06975039130094
- Basic UDI-DI Code
- B-06975039130094
- Reference
- MDD2022MA3375
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Shenzhen PRO HITU Medical Co., Ltd.
Additional Description
High intensity focused ultrasound therapy is a noninvasive method of local treatment. Its principle is to use ultrasound as the treatment source, focus in vitro ultrasonic in vivo to form focal region through its physical properties such as direction, tissue penetration and focus ability, the tissue temperature in the focal region rises rapidly in a very short time, and produce coagulation necrosis. Focal region covers the treatment area by lines, planes and cubes, so as to achieve therapeutic purpose. High intensity focused ultrasound therapy is a new treatment for uterine fibroids, and provides a new choice for the patients of uterine fibroids to retain the uterus and improve the quality of life.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z120610 | ULTRASOUND THERAPY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 7074GB410200529 | DNV MEDCERT GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).