Gynescope Image acquistion system
Basic Information
- Brand Name
- Gynescope Image acquistion system
- Primary DI
- 67290018240016
- Version / Model
- 01
- Catalog Number
- IL-100-100-200
- Company Name
- ILLUMIGYN LTD
- Labeler DUNS
- 600627621
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-26
- Public Version
- 2
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 39c73110-d6e6-4201-bb5f-6463d57cf6eb
Device Description
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 sensor design (a color imaging sensor and a high sensitivity monochrome sensor). The monochrome sensor and the color sensor have the same optical path. The optical design 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 perform examinations of the cervix, combined with a working space for interventional procedures. The Gynescope™ includes an Image Acquisition System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | Obstetrics/Gynecology | 884.1630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64925 | Video colposcope camera/display unit | An electrically-powered device intended to be placed in a video colposcope speculum (not included) to record and display images and videos during examination of the tissues of the vagina, cervix, and external genitalia. It typically consists of an illuminated lens and video camera unit connected to an image display screen/monitor with incorporated software for receiving and viewing the transmitted images/videos. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 67290018240016 | GS1 |
Customer Contacts
- Phone
- +97225476319
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190187 | 000 |