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510(k) Data Aggregation
K Number
K151250Device Name
Smart Set
Manufacturer
TOPSPINS, INC.
Date Cleared
2016-06-07
(392 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
TOPSPINS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended to be used in an MR environment for the Administration of Contrast and Flush for Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA).
Device Description
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K Number
K071140Device Name
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
Manufacturer
TOPSPINS, INC.
Date Cleared
2007-06-07
(44 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
Applicant Name (Manufacturer) :
TOPSPINS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.
Device Description
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K Number
K972663Device Name
SMART SET
Manufacturer
TOPSPINS, INC.
Date Cleared
1997-09-02
(56 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
TOPSPINS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended to be used to assist in : the administration of fluids into a patient's vascular system during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) examination.
Device Description
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