Duns Number:600627621
Device Description: The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging o The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral (White and Green)illumination and multi-angle illumination dark field (side illumination) and bright field (centered illumination) techniques, reinforced with dual imaging sensordesign (a color imaging sensor and a high sensitivity monochrome sensor). The monochrome sensor and the color sensor have the same optical path. The opticaldesign uses a beam splitter adjacent to both of the sensors (at the end of the optical path).The Gynescope™ is a compact colposcope platform for physicians to performexaminations of the cervix, combined with a working space for interventionalprocedures. The Gynescope™ includes an Image Acquisition System
Catalog Number
IL-100-100-200
Brand Name
Gynescope Image acquistion system
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190187
Product Code
HEX
Product Code Name
Colposcope (And Colpomicroscope)
Public Device Record Key
39c73110-d6e6-4201-bb5f-6463d57cf6eb
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
November 26, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |