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510(k) Data Aggregation
K Number
K153239Device Name
LSFG-NAVI
Manufacturer
Date Cleared
2016-05-12
(185 days)
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Softcare Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Laser Speckle Flowgraphy LSFG-NAVI system is intended to capture and display the blood flow distribution in the human retina in real time, and to monitor the blood flow in retinal vessels for their quantitative evaluation.
Device Description
The LSFG-NAVI can visualize and measure the distribution of blood flow in the human retina in a broad area from macular to the optic nerve head. The most useful feature of the instrument is the ability to non-invasively observe varying blood flow synchronized with the heartbeat as a series of 2D blood flow maps.
The LSFG-NAVI consists of following major units:
- (1) LSFG-NAVI Camera Unit: including an emitter of a diode laser, retinal camera imaging system, imager, CCD camera (video capturing)
- (2) Personal Computer (PC): including LSGF-NAVI System Software (Measurement Software and Analysis Software
- (3) 3D-Stage Unit: The LSFG-NAVI Camera Unit is attached to the 3D-Stage unit and a patient places his/her head and face at Chin Rest and Head Rest of the 3D-Stage Unit.
- (4) Electronic Unit: including the AC Adapter and Isolation Transformer.
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