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Found 4 results
510(k) Data Aggregation
K Number
K170978Device Name
Embrace Neonatal MRI System
Manufacturer
Aspect Imaging Ltd.
Date Cleared
2017-07-19
(107 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Aspect Imaging Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Description
The Embrace Neonatal MRI System is a 1Tesla Permanent MRI system producing MR images of Neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.
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K Number
K160185Device Name
Wrist 3
Manufacturer
ASPECT IMAGING LTD
Date Cleared
2016-03-01
(34 days)
Product Code
LNH, MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ASPECT IMAGING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wrist 3 MRI System is intended for use as a magnetic resonance imaging device for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Description
The Wrist 3 MRI System is a 1Tesla Permanent MRI system producing MR images of the wrists and hands. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.
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K Number
K130692Device Name
M2 WRIST 2 MRI SYSTEM
Manufacturer
ASPECT IMAGING LTD
Date Cleared
2014-01-14
(307 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ASPECT IMAGING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M2 Wrist 2 MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.
Device Description
The M2 Wrist 2 MRI System is a 1 Tesla, compact, high-performance solution, based on a permanent magnet. Due to its remarkable structure, the external magnetic field is very low, thus offering unique safety advantage. The system has very low Eddy currents and exhibits very low gradient-related acoustic noise. The magnet is self-shielded and thus no RF shielded room is required. The type of installation is fixed. The M2 Wrist 2 MRI System's main components are: Magnet Sub-system, Wrist Coil, Electronics Cabinet, Aspect Imaging Proprietary Software, Computer, Isolation Transformer.
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K Number
K120701Device Name
M2 WRIST MRI SYSTEM
Manufacturer
ASPECT IMAGING LTD
Date Cleared
2013-02-07
(337 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ASPECT IMAGING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M2 Wrist MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.
Device Description
The Wrist MRI is a 1 Tesla high-performance solution, using NdFeB magnetic material, providing routinely 250 micron or better resolution. The system is Eddy - currents free with gradients which have high strength and a fast slew rate. The Wrist MRI is designed to ensure maximum safety of operation. Its negligible external magnetic-field eliminates the need for a specially shielded room and other limiting operational procedures. The Wrist MRI system's main components are: Magnet Sub-system, Wrist Coil, Electronics Cabinet, Aspect Imaging Proprietary Software, Computer, Isolation Transformer.
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