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Found 4 results
510(k) Data Aggregation
K Number
K243675Device Name
InkSpace Imaging Small Body Array
Manufacturer
InkSpace Imaging, Inc.
Date Cleared
2024-12-20
(23 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
InkSpace Imaging, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 1.5T MRI scanners for body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are flexible to conform to patients' anatomies.
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K Number
K233444Device Name
InkSpace Imaging Small Body Array
Manufacturer
InkSpace Imaging, Inc.
Date Cleared
2024-01-08
(81 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
InkSpace Imaging, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are optimized to be flexible to conform to patients' anatomies.
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K Number
K223487Device Name
InkSpace Imaging Body Array
Manufacturer
InkSpace Imaging, Inc.
Date Cleared
2022-12-08
(17 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
InkSpace Imaging, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pediatric Population: The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis. Adult Population: The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adults, such as spine, shoulder, elbow, knee, foot, and prostate resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Body Array were designed to fit the pediatric and adult populations for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to pediatric and adult patients' anatomies.
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K Number
K213397Device Name
InkSpace Imaging Pediatric Body Array
Manufacturer
InkSpace Imaging, Inc.
Date Cleared
2021-12-17
(60 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
InkSpace Imaging, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InkSpace Imaging Pediatric Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient's anatomy.
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