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The ARTOSCAN M is intended for diagnostic nuclear magnetic imaging of the knee, leg, ankle, foot, hand, wrist forearm and elbow. The device produces transverse, sagittal, coronal and oblique cross-sectional images displaying the internal structure of the anatomy being imaged.

ARTOSCAN M is an MRI system designed specifically to image the extremities: leg (thigh excluded), knee, ankle and foot, forearm, elbow, wrist and hand. A number of modifications have been designed to enhance the functioning of the ARTOSCAN system previously cleared under K931022. The modifications will collectively be referred to as the ARTOSCAN M. Once the modifications described herein are cleared, the ARTOSCAN M will be marketed in place of the original ARTOSCAN device. The difference in the name is very subtle and consists of adding an M after the ARTOSCAN name. Existing ARTOSCAN units (original configuration) can be upgraded to the ARTOSCAN M if the user so desires.

The provided text describes a medical device, the ARTOSCAN M, and its modifications from the original ARTOSCAN system. It details the device's features, intended use, and a comparison table with the predicate device (ARTOSCAN). However, it does NOT include specific acceptance criteria or a study proving the device meets said criteria.

The document is a "Safety and Effectiveness Summary" submitted for 510(k) clearance, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance.

Therefore, I cannot provide the requested information from the provided text. The document acts as a comparison between two device versions, highlighting improvements and equivalence, rather than a performance study with defined acceptance criteria and results.

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