Search Results
Found 2 results
510(k) Data Aggregation
K Number
K171515Device Name
NHAC 16
Manufacturer
Date Cleared
2017-07-26
(63 days)
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
LMT Medical Systems GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NHAC 16 is a local coil (receive only) and is intended to be used in conjunction with 1.5T or 3.0T magnetic resonance imaging (MRI) systems by Philips or Siemens and can be used in conjunction with the MR Diagnostics Incubator System nomag® IC. It provides MR images of the neonatal head, non-invasively and without the use of ionizing radiation.
Device Description
The NHAC 16 is a 16-channel coil (receive only) and is intended to produce high resolution images of the neonate head and brain.
The NHAC 16 serves solely as a receiving coil for the reception of high frequency signals from the hydrogen nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The precessing magnetization induces potential differences in the NHAC 16 which are processed by the MRT system.
Used in an MR Scanner or used in the MR Diagnostics Incubator System nomag® IC and an MR Scanner, the NHAC 16 is indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Hydrogen).
The signal received by the coils is dependent upon the MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift).
Ask a Question
Ask a specific question about this device
K Number
K091047Device Name
NEONATE ARRAY COILS
Manufacturer
Date Cleared
2010-08-18
(492 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
LMT MEDICAL SYSTEMS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used in a MR Scanner or used in the LMT nomag IC incubator and a MR Scanner, the Neonate Array Colls (receive only) are indicated for use as a diagnostic imaging device to provide transversal, sacittel, connel, and chical device to provide (rocolve only) are indicated for use as a diagnostic imaging structures of the structures of the - head (Neonate Head Array Coil) . - spine, torso (Neonate Body Array Coil). . When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Proton). The signal received by the coils is dependent upon the MRI parameters (T1 (Proton). Intice relaxation time. T2 as an and is dependent upon the MRI parameters (T1 or spinlattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift). The Neonate Array coils are compatible to Siemens and Philips MRTs with 1 ET or 3 oT MRTs with 1.5T or 3.0T.
Device Description
The Neonate Array Coils (in the following NAC) is a phased array coil with rectangle loop design and integrated RF preamp per channel. It is a receive-only coil with rectangle for horizontal B-field scanners with field stars of for horizontal B-field scanners with field strengths of 1.5T of 3.0T.
Ask a Question
Ask a specific question about this device
Page 1 of 1