Search Results

The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).

The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.

The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.

This 510(k) summary describes a Picture Archiving and Communications Systems (PACS) Component, specifically the KODAK Digital Science Medical Printer Interface Unit (K961740) and its associated Medical Modality Acquisition Unit. The document explicitly states it is a comparison to a predicate device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device that has been classified as Class II, a classification for devices that are considered to pose a moderate risk to patients and thus require general and special controls to assure their safety and effectiveness.

The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is primarily achieved through a "comparison of features" table, as provided in the document.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document focuses on establishing substantial equivalence to a predicate device based on features and intended use, rather than presenting acceptance criteria and performance study results.

Ask a specific question about this device