Get the free 510(k) Summary for VirtuosoTM System for IHC PR (1E2) - accessdata fda
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This document provides a summary of safety and effectiveness information for the Virtuoso System, a digital pathology and image analysis system intended for in vitro diagnostic use in the automated
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How to fill out 510k summary for virtuosotm
How to fill out 510(k) Summary for VirtuosoTM System for IHC PR (1E2)
01
Begin with the device name: state 'VirtuosoTM System for IHC PR (1E2)'.
02
Provide the submitter's contact information including name, address, and phone number.
03
Describe the intended use of the device, including specific applications in immunohistochemistry.
04
List the device classification and the applicable regulations.
05
Outline the device description, including its components and technologies used.
06
Provide a summary of the performance data supporting the safety and effectiveness of the device.
07
Include any clinical or non-clinical benchmarks used for comparison with predicate devices.
08
Discuss any potential risks associated with the device and the methods of mitigation.
09
Provide labeling information, including instructions for use.
10
Conclude with any additional information relevant to the regulatory assessment.
Who needs 510(k) Summary for VirtuosoTM System for IHC PR (1E2)?
01
Manufacturers who intend to market the VirtuosoTM System for IHC PR (1E2).
02
Healthcare providers seeking to use or implement the device in clinical settings.
03
Regulatory bodies requiring documentation for compliance and safety evaluation.
04
Investors and stakeholders interested in the device's market entry and regulatory approval.
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What is 510(k) Summary for VirtuosoTM System for IHC PR (1E2)?
The 510(k) Summary for the VirtuosoTM System for IHC PR (1E2) is a document submitted to the FDA that provides details on the device's safety and effectiveness, demonstrating that it is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Summary for VirtuosoTM System for IHC PR (1E2)?
The manufacturer or importer of the VirtuosoTM System for IHC PR (1E2) is required to file the 510(k) Summary with the FDA prior to marketing the device.
How to fill out 510(k) Summary for VirtuosoTM System for IHC PR (1E2)?
To fill out the 510(k) Summary, the applicant must include information such as the device description, intended use, comparison to predicate devices, performance testing results, and labeling information.
What is the purpose of 510(k) Summary for VirtuosoTM System for IHC PR (1E2)?
The purpose of the 510(k) Summary is to inform the FDA of the new device's effectiveness and safety, ensuring that it is equivalent to a previously approved device before it can be marketed.
What information must be reported on 510(k) Summary for VirtuosoTM System for IHC PR (1E2)?
The 510(k) Summary must report information such as device classification, intended use, performance data, labeling, and any changes made from the predicate device.
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