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510(k) Data Aggregation
K Number
K020993Device Name
ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
Manufacturer
Date Cleared
2002-05-21
(55 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MAGNA-LAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil.
Device Description
The Illuminator™ Automatic Tuning Interface Box (ATIB) provides an interface for the Illuminator™ Transesophageal Probe, the Illuminator ™ Surface Coil and the General Electric 1.5 T Signa® Magnetic Resonance Imaging (MRI) Systems. The device automatically tunes the Transesophageal (TE) Probe and matches the impedance of the probe to the interface of the MRI system. The Auto Tune Interface Box will be used in clinical MRI rooms. The interface box interfaces with the GE MRI machine through a cable bundle with a 30 pin connector box attached.
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K Number
K010513Device Name
CARDIAC VIEW, MODEL 2001
Manufacturer
Date Cleared
2001-05-21
(89 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MAGNA-LAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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