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510(k) Data Aggregation
K Number
K222259Device Name
NEONA 1.5T MRI System
Manufacturer
Date Cleared
2023-02-21
(208 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Time Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NEONA 1.5T MRI system is indicated for use as a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
Device Description
The NEONA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.
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K Number
K183621Device Name
EMMA 1.5T MRI System
Manufacturer
Date Cleared
2019-02-22
(58 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Time Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
Device Description
The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.
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K Number
K110942Device Name
PICA WHOLE-BODY MRI SYSTEM
Manufacturer
Date Cleared
2011-07-26
(113 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
TIME MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Pica Whole-Body MRI System is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Hybrid Pica may also be used for imaging during interventional procedures when performed with NMR compatible devices such as, in room display and MR safe biopsy needles.
Device Description
Pica Whole-Body MRI System is a 0.35T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RE Transmission Coil, RE Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is an interactive program with user friendly interface. It is a modified system to the existed and cleared Pica Whole Body NMR System (K093984), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.
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K Number
K093984Device Name
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01
Manufacturer
Date Cleared
2010-03-24
(90 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
TIME MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Pica Whole Body MRI System, TMS-MRI-3500WB-01, is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.
It may be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Device Description
Pica Whole Body MRI System is a 0.35T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP Professional is an interactive program with user friendly interface. It is a modified system to the existed and cleared Pica Whole Body MRI System (K091580), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.
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K Number
K092230Device Name
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
Manufacturer
Date Cleared
2009-11-25
(125 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
TIME MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Mona - Orthopedic MRI System is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
Mona - Orthopedic MRI System is a 0.2T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is aninteractive program with user friendly interface.
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K Number
K091580Device Name
PICA WHOLE BODY MRI SYSTEM
Manufacturer
Date Cleared
2009-07-24
(52 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
TIME MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PICA is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Pica may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Device Description
Pica Whole Body MRI System is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is an interactive program with user friendly interface.
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