Search Results
Found 1 results
510(k) Data Aggregation
K Number
K013841Device Name
3DFIS, MODEL IES-FL-101
Manufacturer
3DSHARP, INC.
Date Cleared
2002-01-17
(58 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
3DSHARP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3DFIS is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of desease.
Device Description
The 3DSharp Fluoroscope Image System (3DFIS - Model IES-FL-101) is a stand-alone computer system interfaced to a fluoroscopy and display system through a video cable. The images produced by the fluoroscope are transmitted through a frame capture board in the computer where the images are enhanced and then displayed on the computer's monitor. Each enhanced image is displayed on the 3DFIS monitor as the corresponding original image is displayed on the fluoroscope monitor(s). The 3DSharp Fluoroscope Image System 3DFIS is designed for use in conjunction with any fluoroscope by simple connection. The use of the device enables contrast and brightness enhancement with simultaneous reduction of random noise. The enclosure for the 3DFIS is metal (aluminum). The other components are commercially available hardware and electronic components. The 3DFIS is comprised of three elements. The input element to which the video images from the fluoroscope are connected is a frame capture interface. The computational element, the central component of the system, is a computer. The computer includes several expansion bus slots for the frame capture card and the display interface. The third element is the 3DFIS display. The 3DFIS software controls the frame capture, intermediate image manipulation, and subsequent image display on the 3DFIS monitor. Three image manipulation modes are provided. These are selectable by the user via the computer keyboard. These modes are: RAW: The images are unmodified. AVG: A contiguous sequence of images is averaged together. LIT: These images are modified using the 3DSharp image enhancement method.
Ask a Question
Page 1 of 1