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The Superopen 0.23T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (Ti), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use are as follows:

Anatomical Region: Head, Neck, Shoulder, Breast, Wrist, Ankle, Body, Spine, Knee, Extremities
Nucleus excited: Proton
Diagnostic uses: T1,T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Imaging processing
Imaging capabilities: 2D, 3D Spin Echo( SE ) Turbo spin echo (TSE) Short time inversion recovery (STIR); Fast STIR, IRFFE, IRSE, Fast IR, IR TSE Fluid attenuated inversion recovery (FLAIR); Fast FLAIR 2D,3D Fast Field Echo (FFE) T1/T2/N-Fast field echo (FFE); N-Fast filed echo 3D; T1-Fast field echo 3D; Dual echo (DE);DTSE; DSE; MR angiography FE, FFE 3D; Echo Planar Imaging (EPI)

The Superopen 0.23T (modified) is a 0.23T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, Gradient Coils, RF Coils, Magnet Electronics, Patient Couch, Gradient Amplifier Cabinet, Scan Cabinet, Operator Console, Intercom system. The system software based on Windows XP is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

The Superopen 0.23T (modified) system used the same materials, construction and operating principle as our existing marketed product, Superopen 0.23T MRI system (K062860) and Superstar 0.35T(K071154)

The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria. This 510(k) submission relates to an MRI system (Superopen 0.23T) and primarily focuses on establishing substantial equivalence to previously marketed predicate devices (Superopen 0.23T (K062860) and Superstar 0.35T (K071154)).

The key takeaway from the document regarding performance and testing is:

• Non-clinical test: "The device has been evaluated for performance, biocompatibility and effectiveness as well as electrical, mechanical, chemical, biocompatibility safety and has been found to substantially equivalent to Superopen 0.23T and Superstar 0.35T."
• Clinical test: "No clinical test conducted."

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific study is not available in this document. The manufacturer explicitly states that no clinical tests were conducted for this submission. The substantial equivalence was based on non-clinical evaluations comparing the modified device to its predicates.

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