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K Number
K013099
Device Name
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
Manufacturer
MRI DEVICES CORP.
Date Cleared
2001-09-25

(8 days)

Product Code
MOS
Regulation Number
892.1000
Type
Special
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

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

AI/ML Overview

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.

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.