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510(k) Data Aggregation
K Number
K030540Device Name
HTS ARRAY COIL
Manufacturer
Date Cleared
2003-04-16
(55 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
JOCKEY CLUB MRI ENGINEERING CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MRI array coil for human extremities imaging Anatomical region: Anatomies in human extremities that have cross sectional diameter no larger than 4 "
Device Description
High Temperature Superconducting (HTS) array coil
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K Number
K022863Device Name
HTS COIL
Manufacturer
Date Cleared
2003-02-04
(160 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
JOCKEY CLUB MRI ENGINEERING CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MRI surface coil for peripheral anatomical imaging Anatomical region: Temporo-mandibular joint (TMJ), wrist and other anatomies that are no deeper than 1.5 inches fro the skin.
Device Description
High Temperature Superconducting (HTS) coil
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