Get the free 510(k) Submission -DRC-1000

MD 20993-0002 Medical Device Regulatory Consultant Vatech America SECAUCUS NJ 07094 JUL 2-1 2810 Re K092830 Trade/Device Name Digital X-ray Imaging System /DRC- 1000 Regulation Number 21 CFR 892. Number if known K092830 Device Name Digital X-ray Imaging System /DRC-1000 be used for fluoroscopy angiography or screening mammography. 510 k Submission -DRC-1000 JL2121 510 k Summary Date July 27. 2009 1. Submitter Company Name Vatech Co. Predicate Device Sedecal Inc. Sedecal X-Plus LP Plus Digital...

How to fill out 510k submission -drc-1000

How to fill out 510k submission -drc-1000:

1. Review the instructions provided by the Food and Drug Administration (FDA) for completing the 510k submission form.
2. Gather all the necessary information and documentation required for the submission, such as device identification, intended use, indications for use, and scientific data supporting the safety and effectiveness of the device.
3. Start by providing general information about the device, including its name, manufacturer, and any applicable regulatory numbers or codes.
4. Clearly describe the device's intended use and explain how it differs from similar devices already on the market.
5. Include a comprehensive summary of the device's design, components, and materials used, along with any performance characteristics or specifications.
6. Provide any supporting data, studies, or clinical trials that demonstrate the safety and effectiveness of the device.
7. Ensure that all information is accurate, complete, and in compliance with FDA regulations.
8. Double-check the submission for any errors or missing information before submitting it to the FDA.

Who needs 510k submission -drc-1000:

1. Medical device manufacturers who are seeking clearance from the FDA to market a new medical device in the United States.
2. Manufacturers of medical devices that have made significant changes to an existing device that could potentially affect its safety or effectiveness.
3. Companies that are developing medical devices intended for human use and wish to ensure their compliance with FDA regulations and obtain clearance for marketing purposes.

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What is 510k submission -drc-1000?

510k submission -drc-1000 is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).

Who is required to file 510k submission -drc-1000?

Manufacturers of medical devices are required to file 510k submission -drc-1000.

How to fill out 510k submission -drc-1000?

To fill out 510k submission -drc-1000, manufacturers need to provide detailed information about the device, its intended use, technological characteristics, and performance data.

What is the purpose of 510k submission -drc-1000?

The purpose of 510k submission -drc-1000 is to demonstrate that the device is substantially equivalent to a device already on the market and therefore does not need to undergo a full premarket approval process.

What information must be reported on 510k submission -drc-1000?

The information reported on 510k submission -drc-1000 includes device description, intended use, performance data, comparison to predicate device, and labeling.