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EOS X-ray Image Acquisition System

The EOS solution is a unique combination of innovative, low dose imaging systems and Advanced Orthopedic Solutions designed by EOS imaging. This solution supports radiologists and orthopedic surgeons across the full continuum of care, from initial diagnosis to post-operative evaluations and follow-up. These unique products and services empower physicians to manage their patients and deliver the best treatment outcomes possible.

Unique Imaging Systems

EOS low-dose imaging system enable full body, weight-bearing, high-quality musculoskeletal imaging exams. This powerful tool drive patient safety, facility-wide efficiency, and exceptional clinical value. EOS imaging system is fully integrated with their Advanced Orthopedic Solutions. EOS imaging also offers an ambulatory chair to image non-ambulatory patients.

EOS System

The EOS system delivers low dose stereo-radiographic images of patients in functional positions. EOS technology minimizes patient radiation exposure while providing precise 2D and 3D measurements, free from stitching and magnification bias. Medical teams can leverage these full body, weight-bearing images to better visualize mechanisms between the spine, hip, and knee, enhancing patient treatment across the entire spectrum of care.

The EOS system introduces a fifth medical imaging modality to reduce patient radiation dose and support clinical value. This imaging solution provides comfortable, low dose exams for a wide variety of patients and functional positions. The low dose system provides exceptional image contrast with over 65,000 grey levels.

With the EOS system, healthcare teams can capture full body images (frontal and lateral) in less than 20 seconds, maximizing patient throughput with up to 100 complex exams per day.

The advanced imaging system drives efficiencies across the entire care pathway, from initial diagnosis to follow-up care, improving patient outcomes in the process.

Patient’s radiation dose decreased by 50% compared to a DR system¹ and 85% compared to a CR system²
Substitution of specific CT exams with an EOS exam to reduce the patient’s radiation dose by 95%⁴
Micro Dose protocol for a full spine follow-up exam (frontal and lateral) at a dose that’s equivalent to only a week’s worth of natural radiation³
Exceptional Image Accuracy: EOS exams deliver an accurate view of the musculoskeletal system through full-body, weight-bearing 3D images. The system calculates precise 2D and 3D measurements without magnification or stitching bias.
Improved Diagnostics & Planning: High-accuracy imaging data from EOS allows providers to plan treatment strategies around each patient’s unique 3D anatomy. The low-dose imaging system helps medical experts and their patients co-create the best path to wellness.

References:

1, Comparison of radiation dose, workflow, patient comfort and financial break-even of standard digital radiography and a novel biplanar low-dose X-ray system for upright full-length lower limb and whole spine radiography. Dietrich TJ et al. Skeletal Radiol. 2013.

2, Diagnostic imaging of Spinal deformities: Reducing Patients Radiation Dose With a New Slot-Scanning X-ray Imager. Deschenes S, Charron G, Beaudoin G, Labelle H, Dubois J, Miron M, Parent S. Spine April 2010, 35 (9): 989.

3, EOS microdose protocol for the radiological follow-up of adolescent idiopathic scoliosis. Ilharreborde B. et al. Eur Spine J. 2015.

4, Ionizing radiation doses during lower limb torsion and anteversion measurements by EOS stereoradiography and computed tomography. Delin C et al. Eur J Radiol. 2014.

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F A Q

Is it legal for manufacturers to cope with issues of initial registration without an agent ?

Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.

In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?

Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.

How long is the NMPA review process for the initial registration of the medical device ?

After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.

Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?

MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.