syngo.CT Colonography

syngo.CT Colonography - 11060620

An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NWE

Device Name: Colon Computed Tomography System, Computer Aided Detection

Device Class: 2

Physical State: Computer based software

Definition: To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Detection algorithm searches for and identifies potential polyps or other lesions on images of the colon acquired using multi-slice computed tomography (msct).

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Colon

Regulation Number: 892.2050

Third Party Flag: N

Medical Specialty: RA

Device Id: 04056869026367

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A