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This document provides a summary of the 510(k) premarket notification for the Centricity PACS, a Picture Archiving and Communication System, detailing its intended use, device description, technological

How to fill out centricity pacs traditional 510k

How to fill out Centricity PACS Traditional 510(k) Summary

1. Gather all necessary clinical data and evidence regarding the device.
2. Complete the FDA Form 3514 to submit the 510(k) application.
3. Prepare a summary that includes device description, intended use, and comparison to predicate devices.
4. Include performance testing results, including any bench, animal, or clinical study data.
5. Fill out the safety and effectiveness information, demonstrating how the new device is safe for its intended use.
6. Ensure all labeling information complies with FDA regulations.
7. Review and double-check the entire summary for completeness and accuracy before submission.
8. Submit the 510(k) summary to the FDA for review.

Who needs Centricity PACS Traditional 510(k) Summary?

1. Manufacturers of medical imaging devices that are seeking market clearance.
2. Healthcare providers looking to understand the regulatory pathway for imaging technologies.
3. Investors and stakeholders interested in the marketability and compliance of medical imaging devices.

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What is Centricity PACS Traditional 510(k) Summary?

The Centricity PACS Traditional 510(k) Summary is a document that provides information about the Centricity Picture Archiving and Communication System (PACS) and its compliance with regulatory requirements set by the FDA for medical devices. It outlines how the device is equivalent to a previously approved device.

Who is required to file Centricity PACS Traditional 510(k) Summary?

Manufacturers of the Centricity PACS or any similar medical imaging device that wish to market their products in the United States are required to file a Traditional 510(k) Summary with the FDA.

How to fill out Centricity PACS Traditional 510(k) Summary?

To fill out the Centricity PACS Traditional 510(k) Summary, manufacturers must provide detailed information about the device, including device description, intended use, technological characteristics, comparisons to predicate devices, testing data, and any labeling information.

What is the purpose of Centricity PACS Traditional 510(k) Summary?

The purpose of the Centricity PACS Traditional 510(k) Summary is to demonstrate that the device is safe and effective for its intended use and to establish that it is substantially equivalent to a predicate device that is already approved.

What information must be reported on Centricity PACS Traditional 510(k) Summary?

The information that must be reported on the Centricity PACS Traditional 510(k) Summary includes the device name, the manufacturer's name and contact information, a description of the device, intended use, technological characteristics, performance data, and any labeling or promotional materials.