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 3 components; BASE Assembly, ARM Assembly and Monitor.
Catalog Number
-
Brand Name
DYSIS v3 Digital Colposcope
Version/Model Number
DYS302 - DYSIS v3 ARM Assembly
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
K092433,K092433
Product Code
HEX
Product Code Name
Colposcope (And Colpomicroscope)
Public Device Record Key
f54d6e15-80a2-4e6a-a4ba-82271e7bbd30
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
15060477110017
Quantity per Package
1
Contains DI Package
05060477110010
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 |