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This document provides a summary of the 510(k) premarket notification for the Visix Imaging system, a clinical software application intended for use in medical image management, specifically for dental
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How to fill out section 005_510k summary
How to fill out Section 005_510(k) Summary
01
Begin by gathering the necessary product information, including the intended use and indications for use.
02
Outline the device description, including the design, materials, and technology used.
03
Identify the predicates and provide comparisons, highlighting similarities and differences.
04
Include performance and safety information, such as test results and any clinical data if available.
05
Detail the sterility and shelf life if applicable, along with instructions for use and labeling information.
06
Ensure all relevant regulatory references and standards are cited.
07
Review and verify that all information is accurate and complete before submission.
Who needs Section 005_510(k) Summary?
01
Manufacturers of medical devices seeking FDA clearance to market their devices.
02
Devices that are substantially equivalent to a legally marketed device requiring a 510(k) submission.
03
Any organization or individual involved in the design, manufacture, or regulatory submission of medical devices.
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What is Section 005_510(k) Summary?
Section 005_510(k) Summary is a part of the 510(k) premarket notification process required by the FDA, which provides a summary of safety and effectiveness information for a medical device.
Who is required to file Section 005_510(k) Summary?
Manufacturers of medical devices that are seeking FDA clearance to market their device must file the Section 005_510(k) Summary.
How to fill out Section 005_510(k) Summary?
To fill out Section 005_510(k) Summary, manufacturers need to provide detailed information regarding the device, including its intended use, technological characteristics, and comparisons to predicate devices.
What is the purpose of Section 005_510(k) Summary?
The purpose of Section 005_510(k) Summary is to communicate essential information about the new medical device to the FDA and the public, demonstrating that it is safe and effective for its intended use.
What information must be reported on Section 005_510(k) Summary?
The information that must be reported includes the device name, intended use, description, performance data, any clinical studies, and labeling information.
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