What is the PRO2008?
The PRO2008, manufactured by Shenzhen ProMedical (PRO HITU), is an ultrasound-guided focused ultrasound (USgHIFU) system used in the treatment of uterine fibroids. It focuses ultrasound energy from outside the body onto the target tissue, with planning and monitoring performed under real-time ultrasound imaging. Whether the device can be used for a given patient is always a physician’s decision.
System components
Treatment platform
According to the manufacturer’s documentation, the system uses a top-mounted dry treatment probe, so the patient does not come into direct contact with the coupling fluid. The C-arm structure allows the transducer angle to be adjusted and a suitable acoustic window to be selected; the focal depth can be set and fixed for gynaecological applications.
Imaging and positioning
The system works with wide field-of-view two-dimensional and colour scanning imaging. In the conformal treatment approach, the treatment boundary is set according to the shape of the lesion; the target area is monitored in real time, images are stored and the treatment path is recorded.
Treatment Planning System (TPS)
The TPS handles positioning, lesion outlining and treatment planning: it defines the treatment area according to the actual shape of the fibroid, performs three-dimensional reconstruction and provides assessment based on monitoring images.
The component and function descriptions in this section are based on the manufacturer’s technical documentation; they do not constitute independent clinical outcome data.
Clinical outcome evidence is addressed at method level in our Evidence section.
Source: 2026 · Shenzhen ProMedical (PRO HITU) — üretici tek
Certification and registry status
The manufacturer’s high-intensity focused ultrasound systems are covered by EC certificate HD 2184684-1 issued by TÜV Rheinland (Notified Body 0197); the Turkish Medicines and Medical Devices Agency (TİTCK) has extended the certificate’s validity to 31 December 2028 under the EU transitional provisions.
Source: 2026 · TÜV Rheinland LGA Products GmbH / T.C. Sağlı
The PRO2008 is registered in the Turkish Product Tracking System (ÜTS).
Certification and registration demonstrate legal status; they are not, by themselves, evidence of clinical outcomes.
Source: 2026 · T.C. Sağlık Bakanlığı — Ürün Takip Sistemi
Is treatment with this system right for you?
Device specifications are only one part of that question; what decides it is the characteristics of your fibroids and a clinical assessment of your imaging.
