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The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, foot/ankie, shoulder and elbow regions, as an aid to diagnosis.

The design of the 1.5T and 3.0T 8-channel Medium General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.5T and 3.0T 8-channel General Purpose Flex Coil. The Medium GP Flex Coils are designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot/ankie, shoulder, and elbow. The Medium GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate devices.

This is a traditional 510(k) for an MRI coil, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types for AI/ML performance evaluation is not applicable and cannot be extracted from the provided text.

The document describes the device, its intended use, and its substantial equivalence to a predicate device. The review process for such a device focuses on its physical characteristics, safety, and imaging capabilities rather than AI/ML performance metrics.

Summary of available information:

• Device Name: 1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils
• Manufacturer: Invivo Corporation
• Device Type: Magnetic Resonance (MR) Specialty Coil
• Indication for Use: To produce images of the hip, knee, foot/ankle, shoulder, and elbow regions, as an aid to diagnosis, in conjunction with Philips 1.5T and 3.0T MR scanners.
• Substantial Equivalence: Based on similarities in design features, overall indications for use, and technological characteristics to the predicate device (1.5T and 3.0T 8-channel General Purpose Flex Coil - K093842).

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