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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, ankle, chest, and pelvic regions, as an aid to diagnosis.

The design of the 1.5T and 3.0T 8-channel General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.0T/1.5T/0.5T GE Quad/Phase Array Abdominal Coil. The GP Flex Coils is designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot, chest, and pelvis. The GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate device.

The provided text is a 510(k) summary for the "1.5T and 3.0T General Purpose Flex Coils". This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It does not contain specific acceptance criteria, a study that proves the device meets such criteria, or detailed information about performance metrics, sample sizes, ground truth establishment, or expert involvement in a clinical study.

Therefore, I cannot extract the requested information from the provided text.

The document states:

• "The design of the 1.5T and 3.0T 8-channel General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.0T/1.5T/0.5T GE Quad/Phase Array Abdominal Coil."
• "Substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics."

This indicates that the clearance relies on demonstrating that the new device is fundamentally similar to an already approved device, rather than providing a new performance study against specific acceptance criteria.

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