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510(k) Data Aggregation
K Number
K190786Device Name
Eye Prime
Manufacturer
Ellex Medical Pty Ltd.
Date Cleared
2019-04-11
(15 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Ellex Medical Pty Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eye Prime is intended for ophthalmic imaging when the following conditions are present or suspected:
•Cataracts
•Retinal Detachment (separation of the retina from the middle coat of the eyeball)
•Orbital Lesions
•Tumors
•Foreign Bodies
•Inflammation
•Vascular Irregularities
Device Description
The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device. Its function is to perform B-mode ultrasound scans. The system consists of 1) A console which supports 12 and 18MHz Posterior B scan probes and Anterior B- Scan. Ultrasound Bio-microscopy (UBM) probes with either 35 or 50MHz transducers. 2) A laptop which performs the image processing requirements of the system; provides the user interface for operating the device and viewing the resultant images. The laptop also provides data storage, export, archiving and networking for the device and includes the connection for footswitch.
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