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DYSIS Ultra 2.0

DYSIS MEDICAL LIMITED · Model DYS403 · UDI-DI 05060477110188

510(k) clearances

Adverse events

Recalls

Facilities

Description

DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 6 components; PC, BASE Assembly, Optical ARM Assembly (ARMO), Display ARM Assembly (ARMD), Optical Head Unit and Clinician Touch Screen Monitor.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.