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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician.

Model QWH-420 Wrist Array Coil RF Coil for Magnetic Resonance Imaging Syste

This document is a 510(k) premarket notification letter from the FDA for a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device, a "Model QWH-420 Wrist Array Coil RF Coil for Magnetic Resonance Imaging System," is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Key information present in the document:

• Device Name: Model QWH-420 Wrist Array Coil RF Coil for Magnetic Resonance Imaging System
• Applicant: MRI Devices Corporation
• 510(k) Number: K013099
• Regulation Number: 21 CFR 892.1000
• Regulation Name: Magnetic Resonance Diagnostic Device
• Regulatory Class: II
• Product Code: 90 MOS
• Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician."

Therefore, I cannot provide the requested table and study details as this information is not present in the provided document. The document is a regulatory clearance letter, not a clinical study report or a performance specification document.

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