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K Number
K052497
Device Name
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
Manufacturer
INVIVO CORP.
Date Cleared
2005-10-12

(30 days)

Product Code
MOS
Regulation Number
892.1000
Type
Special
Panel
RA
Reference & Predicate Devices
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 head and neck that can be interpreted by a trained physician.

Device Description

Model NVA-127-16-A Neurovascular Array Coil

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Model NVA-127-16-A Neurovascular Array Coil". This letter is NOT a study report and therefore does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The information provided in the document focuses on:

  • Device Name and Manufacturer: Invivo Corporation, Model NVA-127-16-A Neurovascular Array Coil
  • Regulation Information: 21 CFR 892.1000, Magnetic resonance diagnostic device, Class II, Product Code: MOS
  • Date of Clearance: October 12, 2005
  • Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
  • Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck that can be interpreted by a trained physician."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as it is not present in the provided text.

§ 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.