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510(k) Data Aggregation
K Number
K992892Device Name
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
Manufacturer
Date Cleared
1999-09-16
(20 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MAGNETIC MOMENTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to translate (reposition) the patient manually within a magnetic resonance imaging machine, through the magnet bore, in order to center different regions-of-interest at the center of the magnetic field for either multistation MRA with single dose injection or multistation MRI, using existing system hardware, software and imaging coils.
Device Description
The "SKIP™" table consists of three major components: two platforms consisting of a multitude of nonferromagnetic wheels, or rollers, which contain glass bearings and one overlying movable table. The matrix of all major components consist of plastic material. The axels of the wheels or rollers are also made of plastic material. Small minor components of the device include several straps attached to plastic connectors which are used to immobilize the patient on the moving table and, finally, a plastic mount for suspending the existing MRI imaging surface coil over the patient.
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