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510(k) Data Aggregation
K Number
K130003Device Name
XIRALITE FLOURESCENCE IMAGING SYSTEM X4
Manufacturer
Date Cleared
2014-01-31
(394 days)
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
MIVENION GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Acquiring fluorescent images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands.
Device Description
The Xiralite fluorescence imaging system X4 detects fluorescence signals in the defined field of view using a highly sensitive camera for signal detection and light emitting diodes (LEDs) for excitation. Fluorescence signals typically result from illumination of a specific fluorophore, the fluorescence dye indocyanine green (ICG), which is administered intravenously. Fluorescence signals are recorded at different periodical time points, thus the resulting images display an image sequence. The frame rate is between half a second and a few seconds, typically one second. The duration of the entire image acquisition is dependent on the pharmacokinetics of the administered fluorophore, with ICG typically six minutes.
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