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510(k) Data Aggregation
K Number
K031119Device Name
MAYO CLINIC BC-10 1.5T
Manufacturer
MAYO MEDICAL VENTURES
Date Cleared
2003-07-15
(98 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MAYO MEDICAL VENTURES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mayo Clinic BC-10 1.5T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body which can be imaged.
Device Description
The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.
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