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510(k) Data Aggregation
K Number
K233348Device Name
16 Breast Coil
Manufacturer
Date Cleared
2023-10-24
(25 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Philips Medical System Nederlands B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 16 Breast Coil for Canon 1.5T MRI Scanners are designed to provide magnetic resonance images of breast anatomy when used in conjunction with a magnetic resonance scanner. These images are interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.
Device Description
The 16 Breast Coil is a receive-only coil to be used with 1.5T Orian and Fortian Canon MR scanners. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The 16 Breast Coil is a phased array design consisting of patient support with three different coil combinations (2, 10 or 16 channels). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The 16 Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the 16 Breast Coil allows each imaging element to be independently positioned and configured for each patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject 16 Breast Coil also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s).
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