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510(k) Data Aggregation
K Number
K161871Device Name
EVA (Enhanced Visual Assessment) System
Manufacturer
MobileODT Ltd.
Date Cleared
2016-12-19
(165 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
MobileODT Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The device is intended for use in hospitals, doctor's offices, and remote and rural clinics.
Device Description
The EVA (Enhanced Visual Assessment) System is a handheld device in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, CervDx app for image capture, and online portal for image transfer and remote viewing. The device also includes the strap, carrier case, and instruction manual. During colposcopy, the operator may mount the EVA System on a tripod for hands free imaging, turn on the LED light for improved viewing, see a magnified view of the vagina and cervix on a smartphone screen resting at the back of the device, annotate and save images on the CervDx app, and upload images to the portal. The EVA System is compatible with Motorola G2 and Motorola G3 smartphones.
The EVA System is capable of working for ten hours before recharging. The EVA System weighs about 0.5 kg and is light enough that the device can be operated for 10 minutes at a time without any fatiguing.
The device operates at a working distance of 22.5 - 42.5 cm with an optical magnification up to 4.0x and ultimately up to 16x, with digital zoom.
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