Search Results

MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time-points. MI View&GO supports functional data, such as position emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

MI View&GO is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases associated with oncology, neurology, and organ function. The images and results produced by MI View&GO can also be used by the physician to aid in radiotherapy treatment planning.

MI View&GO is a software-only medical device which will be delivered in conjunction with Siemens SPECT/CT and PET/CT scanners. MI View&GO software provides additional specific capabilities for handling of PET and SPECT as well as CT and MR data directly at the acquisition console.

The MI View&GO software integrates molecular imaging more efficiently in the clinical environment by providing an interface for its users to review, post-process and read medical images immediately after acquisition. The purpose of the MI View&GO is to allow the technologist and reading physician to:

• Review acquired and reconstructed images at the scanner console
• Determine that the acquired data is of sufficient quality for reading, so the patient can be released.
• Prepare images for reading
• Perform a basic read

This FDA 510(k) summary for Siemens' MI View&GO VA20A software describes modifications to an existing medical image management and processing system. The summary does not include a detailed study proving the device meets specific acceptance criteria in the format requested.

The document states that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values." However, it does not provide a table of acceptance criteria and reported device performance, nor does it specify the methodologies, sample sizes, or ground truth establishment for such testing.

Therefore, I cannot provide the requested information from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with quantitative acceptance criteria.

Ask a specific question about this device