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The Doctors Review System (DRS) is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring.

The Doctors Review System is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring. The Doctors Review System is sold either as software alone or as software together with PC based computer parts. The device is available in a variety of configurations, reflecting specific requirements of different specialities. An optional Search package is also available. This program searches the data base of stored reports and list those studies matching the search criteria specified. Links to a variety of ultrasound systems are available as options. The new digital image management option for capturing and displaying digital data is also available as an add-on to the various configurations.

This document does not contain information about acceptance criteria, study details, or specific performance metrics as requested. It is a 510(k) summary for a "Doctors Review System," primarily describing its function as a general-purpose software for creating patient reports. The "Test Discussion" section broadly mentions software verification and validation but does not provide any quantitative results, acceptance criteria, sample sizes, or details about ground truth establishment.

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