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510(k) Data Aggregation
K Number
K122311Device Name
GC-3000E DIGITAL COLPOSCOPE
Manufacturer
Date Cleared
2013-09-18
(413 days)
Product Code
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN GOLDCARE MEDITECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GC-3000E Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.
Device Description
GC-3000E is a digital colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. GC-3000E is used to diagnose abnormalities and select areas for biopsy. GC-3000E acquires and displays high-resolution still and sequentially captured images and videos.
GC-3000E offers non-patient contact, fully digital and high-resolution imaging of the cervix. The field of view is illuminated by circular LED group light source; a high-resolution color CCD camera provides crisp magnified color images. The images can be viewed on a commercially available color monitor.
Components: Digital Camera, Vertical Stand
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