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510(k) Data Aggregation
K Number
K162651Device Name
Breast BI 7 MR Coil Mammavention 3T
Manufacturer
MORAS MRI products GmbH
Date Cleared
2017-01-18
(117 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MORAS MRI products GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Breast Bl 7 MR Coil 3T Mammavention is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device transverse, sagittal, coronal ad oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician.
The coil system Breast Bl 7 MR Coil Mammavention can be used with the following MRI systems:
- 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prisma fit, Spectra
Device Description
The Breast BI 7 MR Coil 3T Mammavention described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 3 T. The coil system serves solely as a receiving coil for the reception of high frequency signals from the hydrogen -('-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the Breast Bl 7 MR Coil 3T Mammavention which are digitized and further processed in the MRT system
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