DYSIS View VIE001

GUDID 05060477110263

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 5 components; PC, BASE Assembly, ARM, Optical Head Unit and Touch Screen Monitor.

DYSIS MEDICAL LIMITED

Colposcope

• Primary Device ID: 05060477110263
• NIH Device Record Key: 401bdf40-6260-40eb-a153-d251387b50d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYSIS View
• Version Model Number: VIE001
• Catalog Number: VIE001
• Company DUNS: 424589138
• Company Name: DYSIS MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060477110263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092433

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-11
• Device Publish Date: 2023-12-01

Devices Manufactured by DYSIS MEDICAL LIMITED

• 05060477110263 - DYSIS View: 2023-12-11DYSIS 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 5 components; PC, BASE Assembly, ARM, Optical Head Unit and Touch Screen Monitor.
• 05060477110263 - DYSIS View: 2023-12-11 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110185 - DYSIS Ultra 2.0: 2019-03-11 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110000 - DYSIS v3 Digital Colposcope: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110017 - DYSIS v3 Digital Colposcope: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 05060477110027 - DYSIS v3 Digital Coploscope: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110062 - DYSIS Ultra: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi