What is the PRO300?
The PRO300 is an ultrasound-guided focused ultrasound (USgHIFU) system built on the PRO2008 platform, distinguished by its six-axis robotic movement system and portable design. It is a Class IIb medical device carrying the CE 0197 mark and is registered in the Turkish Product Tracking System (ÜTS).
How does it differ from the PRO2008?
Both systems work on the same principle: focusing ultrasound energy on the target under real-time ultrasound guidance. What sets the PRO300 apart is its robotic movement system, its miniaturised water processing unit and a design that can move between clinical departments.
Key components
Six-axis robotic movement
According to the manufacturer’s documentation, the treatment head moves through six axes with 360-degree rotation, and the manufacturer states a positioning error below 0.1 mm (utility model patent 210720268364.7). Flexible angle adjustment helps select a suitable acoustic window, and the system raises an automatic alert on physical contact.
aTPS adaptive planning
aTPS is the adaptive version of the planning system that defines the treatment area according to the actual shape of the fibroid; a smaller head allows larger tilt angles, and a dedicated water sac with an adaptive pressure regulator maintains contact between head and body surface.
Compact water processing unit
The unit that prepares the coupling medium measures 420 × 420 × 800 mm and operates with automatic water supply/drainage and semiconductor temperature control.
The component descriptions and figures in this section are based on the manufacturer’s technical documentation and the official PRO300 instructions for use.
The stated robotic positioning accuracy is a manufacturer claim; no independent verification data has been published.
Source: 2023 · Shenzhen PRO HITU Medical Co., Ltd. — resmî
Certification and registry status
An EC Declaration of Conformity has been issued for the PRO300: the device is Class IIb under Directive 93/42/EEC Annex IX, carries the CE 0197 mark (GMDN 57888; UDI-DI 6975039130018), and its EU Authorised Representative is SUNGO Europe B.V.
Source: 2021 · Shenzhen PRO HITU Medical Co., Ltd.
The validity of the related EC certificate has been extended by TİTCK to 31 December 2028, an MDR (EU 2017/745) application has been filed with a written agreement in place with the notified body, and the PRO300 is registered in the Turkish Product Tracking System (ÜTS).
Certification demonstrates legal status; clinical outcome evidence is addressed at method level in our Evidence section.
Source: 2026 · TÜV Rheinland LGA Products GmbH / T.C. Sağlı2026 · T.C. Sağlık Bakanlığı — Ürün Takip Sistemi
