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The VIDAR Vision 2000 is indicated for use in generating radiographic images of human anatomy. It is a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures.

The VIDAR Vision 2000 is not indicated for diagnostic X-ray mammography.

Digital Radiography Image Acquisition System. The device is physically and electrically (including software) identical to the predicate.

The provided text is a 510(k) submission for the VIDAR Vision 2000, which is a Traditional 510(k) submission, not a study. This means it is comparing a new device to a legally marketed predicate device to establish substantial equivalence, rather than providing new performance study data.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical trial or performance study would for a novel device. Instead, it asserts substantial equivalence based on the device being "physically and electrically (including software) identical to the predicate" (K974863).

As such, I cannot populate the requested table and answer the study-specific questions. The document explicitly states:

"The VIDAR VISION 2000 is currently manufactured by IMIX-ADR( Tampere, Finland) under the Premarket Notification of the predicate device (K974863). VIDAR intends to market this device under its own name. The device is physically and electrically (including software) identical to the predicate."

This statement is the core of their submission – they are not conducting a new performance study but rather leveraging the equivalence to an already cleared device.

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