(92 days)
syngo.PET&CT Oncology is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.PET&CT Oncology is a complement to these standard procedures.
The syngo.PET&CT Oncology package is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo.PET&CT Oncology is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PFT or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo.PET&CT Oncology enables visualization of information that would otherwise have to be visually compared disjointedly. syngo.PET&CT Oncology provides anaiytical tools to help the user assess, and document changes in morphological or functional activity at day nostic and therapy follow-up examinations.
syngo.PET&CT Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow up documentation of findings.
The syngo.PET&CT Oncology package is similar to the commercially available TrueD software (K091373), syngoCT Oncology (K071310) and syngo Dual Energy software (K07303) in functionality and usage. syngo. PET&CT Oncology is intended to be run on the Siemens syngo.via software platform (K092519) either alone or with other advanced comment cleared applications.
The provided document is a 510(k) Premarket Notification for the Siemens syngo.PET&CT Oncology software. It details the device's identification, description, indications for use, and a summary of the substantial equivalence determination by the FDA.
However, the document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed methodology of such a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance). The document primarily focuses on establishing substantial equivalence to previously cleared devices based on intended use and technical characteristics, as is common for 510(k) submissions for image processing software.
Therefore, I cannot provide the requested table and detailed information based solely on the provided text. The document refers to risk management and adherence to industry standards, but it does not present the results of performance studies against defined 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).