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The Lucion™ is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.

Mevisys Lucion™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.

I am unable to find any information about acceptance criteria or a study proving that the device meets acceptance criteria in the provided document. The document primarily describes the device (Lucion™ Picture Archiving Communications System), its predicate devices, and its FDA 510(k) clearance for marketing.

The document does not contain:

1. A table of acceptance criteria or reported device performance.
2. Information on sample sizes, data provenance, or ground truth establishment for any test or training sets.
3. Details about expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
4. Confirmation of a standalone performance study.

The description of "Lucion™" indicates it is a PC-based software application that imports and processes medical images (CT, MRI) in DICOM format for display and 3D visualization. It also mentions that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," suggesting it's an aid for human interpretation rather than an autonomous diagnostic device with specific performance metrics.

Therefore,Based on the provided document, the requested information regarding acceptance criteria and performance studies is not available.

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The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.

Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Mevisys VoxelPlus™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.

The provided text does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria. The document is a 510(k) summary for the "VoxelPlus™" Picture Archiving Communications System, which primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information.

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