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510(k) Data Aggregation
K Number
K061532Device Name
GENTLE COLON (REVISION 2.0)
Manufacturer
Date Cleared
2006-09-18
(108 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RENDOSCOPY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rendoscopy's Gentle Colon, revision 2.0, is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM compliant CT scans for the purpose of complete colonic mucosa assessment. The user is capable to assure the colonic mucosa image quality through the following provisions built into the software:
- 3D visualization (3D detection, 2D assessment) .
- No blind areas behind colonic folds due to splitting colon techniques .
- Multi-path tracking system allows path finding over collapsed or liquid- filled . parts of the colon
- The software provides full presentation of cross sectional imaging, such as axial, . sagittal, frontal, oblique, intra-luminal, split colon, topogram view, external and unrolled view of the colon and double contrast visualization
It also includes an automatic report creation facility and is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image study reports utilizing PC hardware.
The target population of the Gentle Colon 3D application is the adult patient. It is intended to be used as adjunctive to standard radiology practices for diagnosis, such as the double contrast/barium enema, of the colon.
Device Description
The Gentle Colon contains all of the required software components to provide interactive 3D views from diagnostic CT scan 2D slice cut images of the colon utilizing PC hardware. The views include cross sectional imaging such as axial, sagittal, frontal, oblique, intraluminal, split colon, topogram view, external view of the colon and double contrast visualization. After the CT scan , axial cuts scanned colon image data are transferred to the Rendoscopy work station. The software loads the data from the CT without the need of manual interaction with the application, enabling the track through the colon including over collapsed parts or over liquid closed lumen.
Surface calculation of the colonic mucosa and splitting of the colon along the track follow automatically. The clip plane is oriented by the maximum curvature of the track, which ensures a free view of the colonic loops or folds.
Rendoscopy's 3D imaging algorithms create surfaces with almost no partial volume effect. Therefore, the 3D images have the highest possible technical contrast resolution, higher than 2D axial cuts.
By splitting the colon the user can get a free view behind the colonic folds, with no distortion. If the gas filled colon tube is interrupted by fluid, or by a collapsed colon part, the user will not run into trouble examining the adjacent colonic part. The Multipath Tracking System will find each path in the 3D dataset without any manual interaction.
This software device provides complete information on cross sectional imaging of any colon location and the information is updated at each step along the track. It is a user friendly, interactive automated Virtual Colonscopy (VC) that uses DICOM data from today's advanced multislice scanners from reputed manufacture. It has been tested and found to work smoothly with different PACS system produced by various manufacturers.
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