K Number
K010721Device Name
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
Manufacturer
Date Cleared
2001-03-30
(18 days)
Product Code
Regulation Number
892.1600AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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