Gynescope Image Acquistion System
The Gynescope Image Acquisition System is the handheld imaging component of the Gynescope colposcope. It provides magnified views of the vagina, cervix and external genitalia for physicians…
The Gynescope Image Acquisition System is the handheld imaging component of the Gynescope colposcope. It provides magnified views of the vagina, cervix and external genitalia for physicians investigating abnormalities and selecting areas for biopsy when indicated. A cable connects it to the system console.
Its optics combine white and green illumination with centered and side lighting. Color and monochrome sensors capture images, with the monochrome sensor used under green illumination. A built-in keypad controls magnification, illumination and image capture.
Listed Item
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
Required Speculum
During use, the imaging component attaches to the Gynescope Single Use Vaginal Speculum. The speculum provides vaginal access and prevents direct contact between the imaging component and the patient. The system is intended for hospitals, clinics and doctors’ offices.
Who Else Makes It
Concentrated in Guangxi (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Goldcare Meditech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| Beijing Tech Instrument Co., Ltd. | Chongwen District | Beijing | Manufacturer | 1 |
Record
| Listed by | Illumigyn Ltd., Israel |
|---|---|
| FDA product code | HEX |
| Device type | Colposcope (And Colpomicroscope) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1630 |
| Establishment | Manufacturer |
| 510(k) | K190187 |
| Record published | 2020-11-26 |
| Record revised | 2022-10-24 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leisegang | Coopersurgical, Inc. | 17 |
| Microscope Colposcope | Ecleris SRL | 16 |
| Bovie | Aspen Surgical Products, Inc. | 15 |
| Henry Schein | Henry Schein, Inc. | 15 |
| Galileo Colposcope, Direct Access | Gynex Corporation | 11 |
| Microstar Colposcope | Ecleris SRL | 11 |
| Wallach | Coopersurgical, Inc. | 7 |
| Kernel | Xuzhou Kernel Medical Equipment Co Ltd | 6 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Unico ColpoMaster I | United Products & Instruments, Inc. | 4 |
| Gynex | Gynex Corporation | 4 |
| medgyn video colposcope | Medgyn Products, Inc. | 3 |
Showing 12 of 42. All products under Colposcope (And Colpomicroscope)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190187 | 2019-05-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.