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510(k) Data Aggregation
K Number
K153416Device Name
ArcScan Insight 100
Manufacturer
ARCSCAN, INC.
Date Cleared
2016-02-02
(69 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ARCSCAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ArcScan Insight 100 is indicated for use in adults to measure dimensions of the human eye. To provide tomographic, high-resolution ultrasound images of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle-to-angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.
Device Description
ArcScan Insight 100 is a precision ultrasound device for imaging and biometry of the eye. It uses a 20-60 MHz transducer that scans the eye in an arc whose curvature approximates the anterior ocular surfaces. Specifically, the ArcScan Insight 100 can measure the thickness of the cornea and its individual layers, the epithelium, stroma, and surgically induced surfaces. Measurements can also be made of the anatomic structures comprising the anterior of the eye such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width. Measurements can be made of pathologic structures such as solid masses and cysts.
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