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EDAN C12A UHD Video Colposcope
EDAN C12A UHD Video Colposcope
The EDAN C12A UHD is a 4K ultra-high-definition video colposcope designed for magnified visual inspection of the cervix, vagina, and vulva in gynecology clinics, colposcopy units, and women‘s health screening programs. It pairs a SONY 4K CMOS sensor (8MP, 3840 × 2160) with a 23.8-inch medical-grade 4K monitor and BT.2020 wide color gamut processing, bringing ultra-high-definition visualization of tissue morphology and vascular characteristics to routine colposcopic assessment.
The C12A UHD is part of EDAN’s UHD Series (C9/C12) of video colposcopes. The device is FDA-cleared under 510(k) K151878 (December 1, 2015) as a Class II video colposcope (21 CFR 884.1630) , with Edan Instruments, Inc. listed as the applicant and the review panel classified under Obstetrics/Gynecology. The system is designed for real-time visualization and documentation of the lower genital tract, supporting image capture, comparison, and archival within the included data management software and DICOM 3.0-compatible workflow.
The imaging chain includes multispectral light source imaging—combining white, blue, and green light to support better visibility of blood vessels and microstructures, with highlighting of vascular differences in cervical intraepithelial lesions. Intelligent gesture recognition enables touch-free control during examinations, reducing lens movement and the risk of cross-infection. Automatic laser ranging provides consistent working-distance measurement, supporting repeatable magnification and focus across examinations and users. An “all-in-one” navigation key supports precise control of magnification and focus, alongside one-click switching between patient information, observation, examination, and analysis interfaces.
The electronic green filter enhances vascular image display without compromising illumination, and the acetic acid and iodine reaction timer supports precise timing of staining reactions during colposcopic assessment. Real-time magnification display and a colposcopic findings gallery support comparison analysis across examinations.
The standard configuration includes a swing arm stand with full set PC/keyboard tray, UHD camera component, 4K image capturing unit, data management software, foot switch, capture card to PC USB cable, and dust cover for the camera. The system operates on AC power via an included adapter, with international power cord options available for different markets.
The C12A UHD is built for gynecologists and colposcopy practitioners who need high-resolution visualization, consistent documentation, and streamlined workflow in cervical screening and lower genital tract assessment—without the image limitations of standard-definition video colposcopes.
Key Features & Benefits
4K UHD Imaging with SONY CMOS and BT.2020 Color Gamut
The SONY 4K CMOS sensor captures 8-megapixel images at 3840 × 2160 resolution, and the 23.8-inch medical-grade 4K monitor displays them without downscaling. BT.2020 wide color gamut support provides a broader color space than conventional sRGB displays, supporting more accurate rendering of tissue color and vascular nuances during colposcopic assessment. Five color spaces and four color gamut options are selectable, alongside seven gamma correction modes to match clinical viewing preferences and documentation standards.
Multispectral Light Source Imaging
The C12A UHD supports white, blue, and green light imaging modes through a multispectral light source, designed to support better visibility of blood vessels and microstructures and highlight vascular differences in cervical intraepithelial lesions. The electronic green filter enhances vascular image display without compromising overall illumination, supporting visualization of vessel patterns that may be relevant to colposcopic assessment.
Gesture Recognition and Automatic Laser Ranging
Intelligent gesture recognition allows touch-free control of key functions during examinations, minimizing lens movement and reducing the risk of cross-infection. Automatic laser ranging provides consistent working-distance measurement, supporting repeatable magnification and focus across examinations and users. An “all-in-one” azimuth key supports precise control of magnification and focus alongside laser distance measurement.
Acetic Acid and Iodine Reaction Timer
The system includes a dedicated timer for acetic acid and iodine reaction assessment, supporting precise timing of staining reactions that are part of standard colposcopic protocols. This function is intended to support consistent documentation of reaction onset and progression during the examination.
Real-Time Magnification and Colposcopic Findings Gallery
Real-time magnification display shows the current magnification level on screen, supporting consistent image documentation across examinations. The colposcopic findings gallery stores captured images for side-by-side comparison analysis, supporting longitudinal review of a patient‘s colposcopic history.
DICOM 3.0 Compatibility and Data Management Software
The included data management software supports patient information management, image capture, and report generation. DICOM 3.0 compatibility enables integration with PACS and hospital information systems where configured, supporting paperless workflow and centralized image archival. PDF report export and HIS/DICOM integration are referenced in distributor documentation for the UHD Series.
Swing Arm Stand with PC/Keyboard Tray and Foot Switch
The swing arm stand with full set PC/keyboard tray provides a stable, adjustable platform for the colposcope head, supporting ergonomic positioning during examinations. The included foot switch allows hands-free capture control during procedures, and the camera dust cover protects the optical components between uses.
Technical Specifications
Why Choose the EDAN C12A UHD?
| Clinical or Operational Challenge | C12A UHD Solution |
|---|---|
| Need high-resolution visualization of tissue morphology and vascularity | SONY 4K CMOS (8MP, 3840×2160) with 23.8-inch 4K monitor and BT.2020 color gamut |
| Need consistent, repeatable magnification and focus | Automatic laser ranging and real-time magnification display |
| Need touch-free control during examinations | Intelligent gesture recognition to minimize lens movement and reduce cross-infection risk |
| Need precise timing of acetic acid and iodine reactions | Dedicated reaction timer for staining assessment |
| Need to compare current findings with prior examinations | Colposcopic findings gallery with side-by-side comparison |
| Need to integrate with PACS/HIS and archive images digitally | DICOM 3.0 compatibility; data management software included |
| Need a stable, hands-free workflow during procedures | Swing arm stand with PC/keyboard tray; included foot switch for capture control |
| Need FDA-cleared equipment for U.S. clinical use | FDA 510(k) K151878 cleared (Class II, 21 CFR 884.1630) |
