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510(k) Data Aggregation
K Number
K113281Device Name
MRI SYTEMS
Manufacturer
Date Cleared
2012-05-17
(192 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN ANKE HIGH-TECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are 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. These images when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
MRI SYSTEMS include a series of open permanent magnet MRI system with magnetic field strength of 0.3T, 0.4T and 0.5T respectively. The model number for each of the corresponding system is ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000) respectively. They are composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil. RF Transmission Coil. RF Receiver Coil. Client PC, and Imaging Cabinet. The system software, APEX, based on Windows XP® Professional is an interactive program with user friendly interface.
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