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This document serves as a 510(k) premarket notification for the Acuson S2000 Ultrasound System, detailing its intended use, classification, and regulatory compliance according to FDA standards for

How to fill out s2000 ultrasound system 510k

How to fill out S2000 Ultrasound System 510(k) Submission

1. Gather all necessary documentation, including product labeling, intended use, and device description.
2. Prepare a summary of the device, detailing its specifications and how it operates.
3. Conduct performance testing and include the results as evidence of safety and effectiveness.
4. Compile comparisons to predicate devices, providing data on similarities and differences.
5. Complete the 510(k) application form accurately, ensuring all required sections are filled out.
6. Provide any additional information requested by the FDA, such as risk analysis or post-market surveillance plans.
7. Review the entire submission for completeness and accuracy before submission.

Who needs S2000 Ultrasound System 510(k) Submission?

1. Manufacturers of the S2000 Ultrasound System seeking market clearance in the U.S.
2. Healthcare providers wanting to ensure compliance with FDA regulations for ultrasound devices.
3. Distributors planning to sell the S2000 Ultrasound System in the U.S. market.

People Also Ask about

What goes into a 510k?

Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).

Can you see 510k submissions?

The FDA maintains a database of premarket notification 510(k) submissions on its official website, enabling users to search for existing submissions using criteria such as the 510(k) number, applicant, device name or FDA product code.

What devices require a 510 k?

A 510(k) is required if the device was manufactured to the inventor's own specifications and is intended to be marketed in the US. FDA clearance through the 510(k) process means the agency agrees with the manufacturer that the medical device is similar to a previously approved predicate device.

What is 5 10k medical device?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

How do you determine if a medical device would require a 510 K approval instead of PMA?

Device classes & premarket requirements that determine 510k vs PMA Class I: These devices are simple, with minimal risk to the user. Class II: Devices in this class pose a moderate level of risk to the user, and all of them require a premarket notification (510k submission) before they can be legally marketed.

For pdfFiller’s FAQs

What is S2000 Ultrasound System 510(k) Submission?

The S2000 Ultrasound System 510(k) Submission is a request for FDA clearance to market the S2000 ultrasound equipment, demonstrating that it is safe and effective for its intended use.

Who is required to file S2000 Ultrasound System 510(k) Submission?

Manufacturers and distributors of the S2000 Ultrasound System who wish to market the device in the United States are required to file the 510(k) Submission.

How to fill out S2000 Ultrasound System 510(k) Submission?

To fill out the S2000 Ultrasound System 510(k) Submission, manufacturers should complete the FDA's 510(k) application form, include device description, intended use, technology comparisons, and required testing data.

What is the purpose of S2000 Ultrasound System 510(k) Submission?

The purpose of the S2000 Ultrasound System 510(k) Submission is to demonstrate to the FDA that the device is substantially equivalent to an already legally marketed device in terms of safety and effectiveness.

What information must be reported on S2000 Ultrasound System 510(k) Submission?

The information that must be reported includes device name, manufacturer's details, intended use, description of the device, performance testing results, labeling, and comparisons with predicate devices.