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K Number
K021575
Device Name
OBC-127 BREAST ARRAY COIL
Manufacturer
MRI DEVICES CORP.
Date Cleared
2002-06-12

(29 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 female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

Device Description

Not Found

AI/ML Overview

The provided text is a clearance letter from the FDA for a device called "OBC-127 Breast Array Coil." It is a premarket notification (510(k)) clearance, which means the device was found to be substantially equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria, device performance, particular studies conducted to prove performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

Instead, the document primarily focuses on:

  • The FDA's decision to clear the device for marketing.
  • The regulatory classification of the device (Class II, Product Code: 90 MOS).
  • General responsibilities under the Act (registration, listing, GMP, labeling).
  • Contact information for various FDA offices.
  • The specific "Indications for Use" for the OBC-127 Breast Array Coil.

Therefore, I cannot provide the requested information based on the given input. The content is an FDA clearance letter, not a study report or clinical trial summary.

§ 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.