Recently, the latest batch of medical device approval document delivery information issued by the National Medical Products Administration (NMPA) was officially publicized. Shandong Aoxin Medical Technology Co., Ltd.’s core product, the 3.0T Extremity Joint Magnetic Resonance Imaging System, has successfully completed the update of its registration status. This marks that the marketing qualification of this world-first specialized high-field MRI product has obtained the latest official confirmation, and also constitutes another important milestone for domestic high-end medical imaging equipment to achieve breakthroughs in specialized segmented tracks.
According to the delivery information disclosed in this public notice, the acceptance number corresponding to Aoxin Medical’s 3.0T Extremity Joint Magnetic Resonance Imaging System is CQY2600557, with the official approval date set as July 28, 2026. This marks another standardized update of registration information completed with the National Medical Products Administration (NMPA) for the product, following its acquisition of China’s first registration certificate for similar extremity joint MRI products back in 2021 (Medical Device Registration No. 20213061095).
Back in June 2026, the National Medical Products Administration (NMPA) issued delivery documents for electronic license correction targeting this product. In accordance with the Administrative Rules for Electronic Medical Device Licenses, which came into force in November 2022, the authority revised and supplemented information on the product’s electronic registration license, further guaranteeing the accuracy and authority of its registration data. From initial approval to standardized improvement of electronic licenses, and then to this latest registration status update, the entire process has strictly complied with national medical device regulatory requirements, laying solid policy support for the compliant deployment of the product in medical institutions at all levels nationwide.
As the world’s first specialized 3.0T magnetic resonance imaging system dedicated to human extremity joints, this product from Aoxin Medical abandons the "large and all-in-one" design concept of conventional whole-body MRI systems and adopts a differentiated technological route featuring specialization, refinement, uniqueness and innovation. Its core components including superconducting magnet, gradient coils and radiofrequency coils are all independently developed with full independent intellectual property rights.
In recent years, Aoxin Medical has successively realized independent R&D of three core components for the world’s first 1.5T large-bore interventional therapeutic MRI: superconducting magnet, gradient coils and radiofrequency coils. Its superconducting magnet features an extra-large bore paired with an ultra-short cavity design, delivering an unobstructed operative field of view for interventional procedures and supporting a wide range of clinical applications including puncture biopsy, drainage and radioactive seed implantation. Meanwhile, the company’s flagship 3.0T Extremity Joint MRI System has been installed and deployed in numerous hospitals and medical institutions nationwide, serving as an elite high-performance device for precise clinical diagnosis and treatment.
In terms of performance metrics, the system is equipped with a 3.0T high-field superconducting magnet that delivers a peak gradient strength of 200 mT/m and a slew rate of 500 T/m/s, with a maximum imaging resolution of 90 micrometers. It clearly visualizes subtle anatomical structures such as articular cartilage, ligaments and trabecular bone that are hard to distinguish with conventional imaging equipment. The average scan time for a single sequence is merely 1.5 minutes, greatly boosting clinical examination efficiency.Additionally, the device adopts an open dedicated scanning design. Patients only need to extend their extremities into the scanning area during examination, completely eliminating the claustrophobia commonly encountered in conventional whole-body MRI scans. This brings a substantial improvement in scanning experience for patients with joint injuries and sports medicine conditions.
According to public corporate disclosures, the product will undergo an AI function upgrade in 2026. Technologies including AI sampling acceleration, AI noise reduction filtering and AI-aided diagnosis will be integrated into the existing system to further enhance diagnostic accuracy for specialized imaging and deliver more efficient auxiliary diagnostic tools for clinicians.
Import brands have long dominated China’s domestic high-end MRI market. Instead of engaging in homogeneous competition in the red ocean market, Aoxin Medical has targeted the segmented extremity joint sector, where clinical demands have long remained underserved. Its 3.0T Extremity Joint MRI System has earned numerous prestigious industry honors, including the First Prize of Beijing Municipal Science and Technology Progress Award and Silver Award at Shandong Provincial Governor’s Cup Industrial Design Competition.The enterprise has been certified as a provincial-level Specialized, Refined, Unique & Innovative (SRUI) Enterprise and a Gazelle Enterprise of Shandong Province. R&D staff account for one-third of its total workforce, and annual R&D investment has consistently stayed above 50% of operating revenue.
Compared with other peers adopting differentiated strategies in the industry, Aoxin Medical has opted for the 3.0T superconducting high-field technical route, which creates an obvious generational technology gap against extremity joint MRI products equipped with 0.25T permanent magnets. It also achieves dislocation and complementary development with domestic counterparts focusing on infant brain MRI and dedicated breast MRI, jointly fostering a diversified innovation ecosystem for domestic high-end medical imaging equipment.
While consolidating its market advantages in the existing 3.0T extremity joint MRI segment, Aoxin Medical is steadily advancing its next flagship product — the world’s first 1.5T extra-large bore interventional therapeutic MRI. Approximately 80% of its clinical research had been completed as of April 2026. Equipped with an ultra-short cavity superconducting magnet, this system delivers an ample operative field of view for interventional procedures such as puncture biopsy and radioactive seed implantation. It is expected to deliver another world-leading breakthrough for domestic interventional imaging equipment in the near future.
With the successful update of registration status approved by the NMPA, Aoxin Medical’s 3.0T Extremity Joint MRI System will further accelerate its deployment and popularization in specialized medical institutions nationwide, including hand and foot surgery, sports medicine and orthopedics departments. More patients will have access to accurate and convenient diagnostic services delivered by domestic high-end specialized imaging devices, marking another milestone along the path of independent innovation for China’s high-end medical equipment industry.
