Search Results

G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.

The changes performed on the modified G-scan device, with respect to the cleared version – G-scan K042236 –, are due to the improvement of the system safety and performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A modified version of the magnet poles and of the gradient coils.
• 2. New receiving coils.
• 3. Modified pulse sequences.
• 4. A new Emergency button procedure.
• 5. A new safety device named sensitive edge.
• 6. A new safety switch named "Bed in"
• 7. A hand protection for patient table.
• 8. A head protection for patient table.
• 9. An exam positioning indicator kit for patient table.
• 10. A new step for patient positioning.
• 11. Contraindications have been added in the user manual due to the possibility of patient syncope caused by protracted orthostatic positions required for the examination.
• 12. A new software release.

The provided 510(k) summary for the G-Scan MR system does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria. This summary focuses on demonstrating substantial equivalence to a predicate device based on modifications to an existing and cleared MR system.

Here's why and what information is missing:

• Focus on Substantial Equivalence: The document is a 510(k) summary, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, rather than presenting de novo performance studies against specific acceptance criteria.
• Modifications, Not New Device: The G-Scan discussed is a modified version of an already cleared device (G-scan K042236). The modifications listed (magnet poles, coils, pulse sequences, safety features, software) are presented as improvements to safety and performance that "do not affect the intended use or alter the fundamental scientific technology of the device." This context suggests that extensive new performance studies (like those for a novel AI device) against acceptance criteria were likely not deemed necessary for this type of submission.
• Interpretation by Medical Expert: The "Indications for Use" section states: "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This implies that the diagnostic performance is ultimately dependent on a human expert, not solely on an algorithmic output against predefined metrics.

Therefore, I cannot provide the requested table and details as they are not present in the provided text. The document is concerned with the safety and technological equivalence of an updated magnetic resonance imaging system, not the analytical or clinical performance of an AI algorithm against specific acceptance criteria.

Ask a specific question about this device