Device Description : DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image 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 3 components; BASE Assembly, ARM Assembly and Monitor.
Device Class : 2
Duns Number: 424589138
Premarket Exempt : No
Prescription Use : No
Device Description : DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image 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 3 components; BASE Assembly, ARM Assembly and Monitor.
Device Class : 2
Duns Number: 424589138
Premarket Exempt : No
Prescription Use : No
Device Description : DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image 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 3 components; BASE Assembly, ARM Assembly and Monitor.
Device Class :
Duns Number: 424589138
Premarket Exempt : No
Prescription Use : No
Device Description : DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image 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 7 components; PC, BASE Assembly, Optical ARM Assembly (ARMO), Display ARM Assembly (ARMD), Optical Head Unit, Clinician Touch Screen Monitor and Patients Monitor.
Device Class : 2
Duns Number: 424589138
Premarket Exempt : No
Prescription Use : No
Device Description : DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image 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.
Device Class : 2
Duns Number: 424589138
Premarket Exempt : No
Prescription Use : No