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The document provides a summary of the safety and effectiveness information for the RAYSCAN a-Expert 3D dental imaging device submitted to the FDA as part of a 510(k) premarket notification.
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How to fill out 510k submission- raysgan a-expert
How to fill out 510(k) Submission- RAYSGAN a-Expert 3D
01
Gather all necessary documentation including device description, intended use, and labeling.
02
Conduct a risk assessment to determine potential hazards associated with the device.
03
Identify and provide performance testing data to demonstrate safety and effectiveness.
04
Compile summary of substantial equivalence to a predicate device already on the market.
05
Complete the 510(k) form electronically using the FDA's submission portal.
06
Include any financial disclosures if applicable.
07
Submit the application along with the required fee to the FDA.
Who needs 510(k) Submission- RAYSGAN a-Expert 3D?
01
Manufacturers of medical devices seeking to market their product in the U.S.
02
Companies introducing a new version of an existing device that requires clearance.
03
Businesses wanting to ensure compliance with FDA regulations for medical devices.
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What is 510(k) Submission- RAYSGAN a-Expert 3D?
The 510(k) Submission for RAYSGAN a-Expert 3D is a premarket submission made to the FDA to demonstrate that a device is safe and effective, and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Submission- RAYSGAN a-Expert 3D?
Manufacturers of medical devices that are not exempt and intend to market their devices in the U.S. market, including those developing the RAYSGAN a-Expert 3D device, must file a 510(k) submission.
How to fill out 510(k) Submission- RAYSGAN a-Expert 3D?
To fill out a 510(k) Submission for RAYSGAN a-Expert 3D, manufacturers need to complete the FDA's 510(k) form, provide device descriptions, labeling information, performance data, and comparisons to predicate devices.
What is the purpose of 510(k) Submission- RAYSGAN a-Expert 3D?
The purpose of the 510(k) Submission for RAYSGAN a-Expert 3D is to obtain FDA clearance to market the device by proving it is safe and effective for its intended use compared to existing devices.
What information must be reported on 510(k) Submission- RAYSGAN a-Expert 3D?
In the 510(k) Submission for RAYSGAN a-Expert 3D, information that must be reported includes device identification, intended use, technological characteristics, performance data, labeling, and comparison to predicate devices.
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