Search Results

The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured as a stand-alone diagnostic post-processing and reporting workstation.

The X-LEONARDO can be configured with a variety of syngo- or Windows -based software options which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques and OEM options

This Premarket Notification covers Siemens X-LEONARDO syngo-based multimodality workplace. syngo is a universal imaging platform based on Windows XP. The X-LEONARDO Workstation offers a comprehensive solution to view, optimize, and post-process diagnostic information and to aid the doctors in the evaluation of digital radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the X-LEONARDO Workstation can be configured with different combinations of clinical applications. syngo applications can be added to the X-LEONARDO multi-modality workplace either individually or as clinical focus packages.

The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The X-LEONARDO can be configured with a variety of syngo- or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available OEM applications.

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The submission, K042995 for the Siemens X-LEONARDO Workstation, is a 510(k) Premarket Notification. For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a formal clinical study with performance metrics.

Instead, the submission focuses on:

• Device Description and Intended Use: Defining what the X-LEONARDO Workstation is and what it's used for (viewing, manipulation, communication, and storage of medical images and data).
• Technological Characteristics: Describing its software (syngo-based, Windows XP), DICOM compatibility, and how it's marketed (software-only or complete workstation).
• General Safety and Effectiveness Concerns: Mentioning risk management through risk analysis, software development, verification, and validation testing, and adherence to industry standards to minimize hazards.
• Substantial Equivalence: Explicitly stating that the X-LEONARDO Workstation is substantially equivalent to the LEONARDO Workstation (K040970) because it has the "same intended use and similar technical characteristics."

Therefore, I cannot populate the table or provide the requested study details as this information is not present in the given text. A 510(k) submission for a PACS workstation typically does not include detailed performance acceptance criteria or a comparative effectiveness study in the way an AI diagnostic device might. The "performance" is implicitly tied to its function as a viewing and processing workstation, and its substantial equivalence to a predicate device already on the market.

Ask a specific question about this device