Gynescope, Console System
The Gynescope console processes, stores and displays images from the system’s handheld image acquisition unit. It supports physicians examining the vagina, cervix and external genitalia and…
The Gynescope console processes, stores and displays images from the system’s handheld image acquisition unit. It supports physicians examining the vagina, cervix and external genitalia and reviewing magnified tissue images when investigating abnormalities or selecting a biopsy site.
A 12.2-inch touchscreen provides controls for magnification, illumination and image capture on the connected acquisition unit. The console receives image data through a cable and includes a video output for connection to a separate display.
Listed Item
Gynescope™ system console for image capturing and digital image archiving
System Components
The console is used with the compatible Gynescope image acquisition unit and single-use vaginal speculum in hospitals, clinics or doctors’ offices. A cradle on the console holds and protects the acquisition unit between uses.
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 |
|---|---|
| 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.