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510(k) Data Aggregation
K Number
K962260Device Name
REAL-TIME VIDEO CONTRAST ENHANCER
Manufacturer
DIGIVISION, INC.
Date Cleared
1996-09-09
(89 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DIGIVISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CE-3000 Contrast Enhancer like the FluoroVision, may be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy. Despite the different indication statements, both devices have the same function and purpose and the differences in intended use does not create new safety or effectiveness issues.
Device Description
The CE-3000 takes a video signal in and allows an operator to control, via three knobs on the front panel, the local gain of spatial frequencies, through high specd signal processing, to generate video optimized for specific functions in real time. The three knohs on the front of the device, DETAIL (kernel size), CONTRAST and BACKGROUND, allow the operator to "dial-in" the picture to his preference or he may press the PRESET button to set the cnhancement to predetermined factory settings. A SPLIT screen button is available to help the user to set the optimum enhancement. Selecting the BYPASS switch displays original unprocessed video.
The CE-3000 has a main processor circuit board (core board) which incorporates DigiVision. Inc.'s patented V-Lace technology (for video locally adaptive contrast enhancement) can be adjusted to give the appropriate enhancement to any video scene. The image processing algorithm is expressed as:
Y = c(X · X_bar(d)) + (l · b)X_bar(d) + bM.
The CE-3000 incorporates software as embedded software in the micro controller which is used, in turn to program an EEPROM. There exists no user changeable software.
The enclosure for the CE-3000 is metal (aluminum). The other components are commercially available hardware and electronic components and printed circuit cards manufactured to DigiVision, Inc. specifications.
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