(202 days)
Cliniview software program is indicated for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
Cliniview software has the functionality which compares with the functionality provided by VixWin Platinum predicate cleared under K141451, the DEXIS Software predicate cleared under K140445 and the Romexis predicate cleared under K140713.
Scanora software is equal with the Cliniview software with branding labeling differences. Scanora is product name for Soredex brand imaging products whereas Cliniview is for Instrumentarium Dental imaging products. There is no difference in design. Cliniview 11 equals Scanora 6. This submission discusses about Cliniview software covering Scanora software at the same time.
Cliniview software program is indicated for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
The types of images handled by Cliniview include, for example, panoramic, cephalometric, CBCT, intra-oral, and color photographs, Images can be viewed from a workstation, a mobile application or using a web browser. The Mobile Application is not intended for diagnostic use.
Cliniview image acquisition supports imaging plates, intraoral sensors and digital X-ray imaging devices. Images can also be imported from other digital sources. Cliniview stores images and patient information in the SQL database and provides tools for image archiving. Cliniview has interfaces to 3rd party systems through the proprietary dental practice management system interface and DICOM standard interface.
The main features of the Cliniview software include patient management, image acquisition, patient and image data storage, image viewing of 2D images and processing and enhancement of images.
Cliniview software can be utilized either locally or over a networked environment. If Cliniview is installed on several computers, the patient and image database can be shared among them and used from different workstations.
The provided text is a 510(k) summary for the Cliniview software, which is a Picture Archiving and Communications System (PACS) for dental and maxillofacial diagnostic imaging. It describes the device's intended use, technological characteristics, and its comparison to predicate devices, but it does not contain any information about acceptance criteria, specific performance data (e.g., accuracy, sensitivity, specificity), sample sizes for test or training sets, expert qualifications, or adjudication methods.
Therefore, I cannot extract the requested information as it is not present in the provided document.
To fulfill your request, the document would need to include details of a clinical study or performance evaluation with quantifiable metrics for the Cliniview software's performance, alongside predefined acceptance criteria.
§ 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).