NWE · Colon Computed Tomography System, Computer Aided Detection
Radiology · 21 CFR 892.2050 · Class 2
Overview
| Product Code | NWE |
|---|---|
| Device Name | Colon Computed Tomography System, Computer Aided Detection |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140920 | SYNGO.CT COLONOGRAPHY | Siemens Medical Solutions USA, Inc. | Dec 3, 2014 | SESE |
| K083423 | COLONCAD API 3.1 | Medicsight Plc | May 17, 2011 | SESE |
| K042674 | COLON CAR 1.2 | Medicsight | Oct 19, 2004 | SESE |
| K042605 | COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | Oct 8, 2004 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 1 clearance
- Siemens AG Medical Solutions — 1 clearance
- Medicsight Plc — 1 clearance
- Medicsight — 1 clearance
