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510(k) Data Aggregation
K Number
K213480Device Name
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
Manufacturer
Date Cleared
2023-02-01
(460 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
RAPID Biomedical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Head Coil is indicated for use as diagnostic device extension for a Philips, Siemens or GE 3.0 T MR system to provide cross-sectional 1H and/or any X nucleus images, spectroscopic images and/or spectra in any orientation of the internal structure of the head of the patient. These images when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The Head Coil is used in Magnetic Resonance Imaging and Spectroscopy (MRI, MRS). The Head Coil has been designed to be used on Siemens, Philips or GE 3.0 T MR systems. The Head Coil is a transmit/receive coil to excite and detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23 Na) nuclei. Excitation of the nuclei is achieved by applying an RF magnetic field. The detected signal is an RF voltage being induced in the Head Coil by the nuclei observed. The Head Coil mainly offers passive antenna technology for linking the MR system to the patient (and reverse).
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K Number
K191539Device Name
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
Manufacturer
Date Cleared
2020-01-31
(235 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Rapid Biomedical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Endorectal Coil is indicated for use as diagnostic device extension for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, displaying the internal structure of the prostate.
These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The Endorectal Coil (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946, 3.0T Endorectal Coil O-HLE-030-01900 and ER Coil Support ZUB-01955) is designed for use with a magnetic resonance (MR) system. The coil is designed to work in unison with the Body Coil (BC) of the MR system, which will excite the hydrogen (1H) nuclei with radio frequency (RF) magnetic fields, so that the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as a reusable receive-only coil for high resolution MR examination of the prostate.
The coil housing is minimum sized and drop-shaped for better patient comfort. It features a flat top to minimize the distance of the inside receive coil electronics to the prostate. The coil is receive-only (Rx) and consists of a single loop coil element with an integrated low noise preamplifier and a connector to the GE 1.5 T MR-System or GE 3.0 T MR-System. The coil is fixed tuned and matched to the typical loading condition of a prostate examination at the Larmor frequency of 1H at 1.5 T (63.9 MHz) or 3.0 T (127.7 MHz), respectively. Decoupling circuits are integrated in the single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse.
It is recommended to employ an Endorectal Coil Model in combination with the additional available ER Coil Support. The ER Coil Support is designed for use with any Endorectal Coil Model (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946 and 3.0T Endorectal Coil O-HLE-030-01900). It supports stabilizing the Endorectal Coil in any position required by each individual endorectal MR examination. The ER Coil Support features a collet for acceptance of the Endorectal Coil. The Endorectal Coil is fixated inside the collet by tightening of a knurled screw. It offers five degrees of freedom to align the position of the collet with the required spatial position of the Endorectal Coil housing. Two additional knurled screws allow the lock the ER Coil Support in the desired alignment.
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K Number
K181948Device Name
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
Manufacturer
Date Cleared
2018-11-16
(119 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
RAPID Biomedical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 16Ch Diagnostic Breast Coils are indicated for use as diagnostic imaging device extensions for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images and/ or spectra, and that displays the internal structure of the breast. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The 16Ch Diagnostic Breast Coil (1.5 T 16Ch Diagnostic Breast Coil and 3.0 T 16Ch Diagnostic Breast Coil) is designed for use with a magnetic resonance (MR) system. The coil is designed to work in unison with the Body Coil (BC) of the MR system, which will excite the hydrogen (1H) nuclei with radio frequency (RF) magnetic fields, so that the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as a receive-only coil for high resolution MR examination of breast.
The coil housing features a curved surface for better adaption to the anatomical region of interest. The coil is receive-only (Rx) and consists of 16 independent single loop coil elements with integrated low noise preamplifiers and a connector to the GE 1.5 T MR Systems or the GE 3.0 T MR Systems. The coil is fixed tuned and matched to the typical load of a breast at the Larmor frequency of 1H at 1.5 T (63.9 MHz) or 3.0 T (127.7 MHz) respectively. Decoupling circuits are integrated in each single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse. The coil provides both, unilateral and bilateral images (Left, Right and Both) of the anatomy of interest.
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K Number
K163661Device Name
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
Manufacturer
Date Cleared
2018-03-21
(449 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
RAPID Biomedical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce cross-sectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are single tuned surface type transmit and receive coils for usage in magnetic resonance systems, the operating frequency and interface being adapted for usage on Philips 3.0 T MR Systems. The coils are for transmit and receive (T/R) and provide the required magnetic RF field for excitation of the spins and receive the MR signal of 31P, 23Na or 13C spins. This is used for axial, sagittal, coronal and oblique imaging, spectroscopic imaging and/or spectroscopy, which display the internal structure and/or function of the human anatomy, e.g. of the calf, liver or heart.The coils are optimized for local examinations of human subjects. The housing is flexible for better adaption to the anatomical region of interest. The coils consist of a single loop (linear) with a diameter of 14 cm, RF routing (T/R switch), a low noise preamplifier and a connector to the Philips 3.0 T MR Systems. The coils are fixed tuned and matched to the typical load of human tissue at the Larmor frequency of 31P (51.7 MHz), 23Na (33.8 MHz) or 13C (32.1 MHz) at 3.0 T. There is no detuning or switching mechanism in the loops. The loops are tuned permanently to the working frequencies of 31P, 23Na or 13C while being decoupled from the 1H body coil at the 1H frequency.
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K Number
K102748Device Name
31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
Manufacturer
Date Cleared
2011-05-13
(232 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
RAPID BIOMEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dual Tuned Head Coils 3T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The Dual Tuned Head Coils 3T are transmit/receive volume coils to detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23Na) nuclei. Each coil consists of two single quadrature resonators, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus, carbon or sodium frequency.
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K Number
K102348Device Name
31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T
Manufacturer
Date Cleared
2010-12-22
(125 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
RAPID BIOMEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on l H (proton) and either 31P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The Dual Tuned Surface Coils 3 T are transmit/receive surface coils to detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23Na) nuclei. Each coil consists of two single concentric loops, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus-31P, carbon-13C or sodium-23Na frequency. Additional components are housed in a separate interface housing box.
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K Number
K083255Device Name
16CH AI BREAST COILS 1.5 T AND 3 T
Manufacturer
Date Cleared
2008-11-21
(17 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
RAPID BIOMEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast.
Device Description
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are receive only MR coils for imaging the human breast. Both coils consist of 16 coil elements. Two housing halves each contain eight independent coil elements. Seven of each are arranged in a cylindrical geometry while one element is positioned in a horizontal plane at top of the cylinder faced outwards.
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