Duns Number:424589138
Device Description: DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervi 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.
Catalog Number
-
Brand Name
DYSIS Ultra 2.0
Version/Model Number
DYS403
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092433,K092433
Product Code
HEX
Product Code Name
Colposcope (And Colpomicroscope)
Public Device Record Key
50211cb7-e0eb-42dd-b465-398ffcd8ca9c
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 22, 2019
Package DI Number
15060477110185
Quantity per Package
1
Contains DI Package
05060477110188
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |