Get the free 510(k) Summary for syngo.plaza VA20A - accessdata fda
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This document provides safety and effectiveness information for the syngo.plaza VA20A, a Picture Archiving and Communication System used for digital medical imaging.
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How to fill out 510k summary for syngoplaza
How to fill out 510(k) Summary for syngo.plaza VA20A
01
Obtain the required forms and guidelines from the FDA website.
02
Begin with a clear title that specifies the product name and the intended use.
03
Provide a summary of the device, including its operating principles and any technological characteristics.
04
List the intended use of the device as it relates to the market.
05
Include a detailed description of the design and materials used in the construction of syngo.plaza VA20A.
06
Compare the device to a legally marketed predicate device, demonstrating similarities and differences.
07
Provide performance testing data, including bench tests, animal studies, or clinical data if applicable.
08
Ensure that all safety and efficacy data are comprehensive and clearly presented.
09
Summarize any potential risks associated with the device and how they are mitigated.
10
Review and finalize the document, ensuring adherence to FDA formatting and submission requirements.
Who needs 510(k) Summary for syngo.plaza VA20A?
01
Manufacturers of the syngo.plaza VA20A need to submit a 510(k) Summary to demonstrate that their device is safe and effective compared to an existing, legally marketed device.
02
Healthcare professionals and practitioners may refer to the 510(k) Summary for device information and substantiation of claims.
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What is 510(k) Summary for syngo.plaza VA20A?
The 510(k) Summary for syngo.plaza VA20A is a document submitted to the FDA that provides details about the device's safety and effectiveness, including data and information that demonstrate that the device is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Summary for syngo.plaza VA20A?
The manufacturer or importer of the syngo.plaza VA20A device is required to file the 510(k) Summary with the FDA before marketing the device.
How to fill out 510(k) Summary for syngo.plaza VA20A?
To fill out the 510(k) Summary for syngo.plaza VA20A, the filer must provide detailed information including the device description, intended use, technological characteristics, performance data, labeling, and substantial equivalence rationale.
What is the purpose of 510(k) Summary for syngo.plaza VA20A?
The purpose of the 510(k) Summary for syngo.plaza VA20A is to demonstrate that the device is safe and effective for its intended use and is substantially equivalent to an existing device that is already cleared by the FDA.
What information must be reported on 510(k) Summary for syngo.plaza VA20A?
The 510(k) Summary for syngo.plaza VA20A must report information including the device name, classification, intended use, descriptions of the device, substantial equivalence claims, and any relevant safety and effectiveness data.
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