(44 days)
XELIS™ is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.
XELIS is a CT colonography dedicated workstation designed to help radiologists to examine images. XELIS receives DICOM compliant CT images from a remote PACS server. Both primary 2D and primary 3D review modes are supported to meet the various needs of users.
- Real-time and one-pass navigation based on an unfolded view to show complex inner wall of colon.
- Automatic centerline extraction combining with easy selection UI to help fast path setup.
- Tagged-stool overlay on endoluminal and band view to enable to handle CT images with minimal preparations.
- Batch capture for reconstructed images related to lesions during the exam to report and send to clinicians.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. It describes the device, its indications for use, and confirms its substantial equivalence to predicate devices based on regulatory requirements (510(k) submission).
Therefore, I cannot populate the table or answer the specific questions about a study.
The document mainly covers:
- Device Name: XELIS™
- Common Name: Picture Archiving Communications System
- Classification: Radiological image processing system (21 CFR 892.2050, Product Code LLZ)
- Predicate Devices: K041761 (RAPIDIACOLON) and K052545 (INFINITT G3 PACS)
- Device Description: A CT colonography dedicated workstation for 2D and 3D visualization of colon images, supporting real-time navigation, automatic centerline extraction, tagged-stool overlay, and batch capture.
- Indications for Use: Software-based device for display and visualization of 3D and 2D medical image data of the colon. Images are for display and diagnosis by radiologists, clinicians, and referring physicians as an adjunct to standard radiology practices. It explicitly states that analysis of images and diagnosis is not performed by the software.
- Technological Characteristics: Software device, no patient contact, does not control life-sustaining devices, human interpretation required.
- Conclusion: Determined substantially equivalent to predicate devices.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).