FDA.reportPublic FDA data

Noras Mri Products GmbH

Matched from indexed company URL: NORAS MRI PRODUCTS GMBH

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Breast BI 7 MR Coil Set 3T - The intended use of the Breast Coil 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 to produce transverse, sagittal, coronal and 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 placement of localization-wire by a trained physician.

Noras MRI products GmbH

2025-04-09

Breast BI 7 MR Coil Set 1.5T - The intended use of the Breast Coil 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 to produce transverse, sagittal, coronal and 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 placement of localization-wire by a trained physician.

Noras MRI products GmbH

2023-09-08

Breast BI 7 MR Coil Set 3T - The intended use of the Breast Coil 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 to produce transverse, sagittal, coronal and 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 placement of localization-wire by a trained physician.

Noras MRI products GmbH

2023-09-08

Breast BI 7 MR Coil Set 1.5T - The intended use of the Breast Coil 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 to produce transverse, sagittal, coronal and 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 placement of localization-wire by a trained physician.

Noras MRI products GmbH

2023-07-14

Breast BI 7 MR Coil Set 3T - The intended use of the Breast Coil 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 to produce transverse, sagittal, coronal and 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 placement of localization-wire by a trained physician.

Noras MRI products GmbH

2023-05-22

OR Head Holder LUCY with HeadCoilSet Philips 1.5T - The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery. The OR Head Holder LUCY is used for safe securing the patient’s head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging, in the X-ray environment it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

Noras MRI products GmbH

2023-05-11

OR Head Holder LUCY with HeadCoilSet Philips 3T - The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery. The OR Head Holder LUCY is used for safe securing the patient’s head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging, in the X-ray environment it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

Noras MRI products GmbH

2023-05-11

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