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This document summarizes the 510(k) submission for the Siemens Acuson S2000 Diagnostic Ultrasound System, detailing device specifications, intended uses, technological characteristics, and regulatory

How to fill out s2000 ultrasound system 510k

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

1. Gather necessary information about the S2000 Ultrasound System, including specifications and intended use.
2. Review the FDA guidelines for 510(k) submissions to ensure compliance with all requirements.
3. Complete the 510(k) cover sheet, including contact information and device details.
4. Prepare a summary of the S2000 Ultrasound System, highlighting its features and benefits.
5. Conduct a comparison with a predicate device to demonstrate substantial equivalence.
6. Compile performance testing data and any clinical data, if applicable, to support the submission.
7. Include labeling information and user manuals that will accompany the device.
8. Submit the 510(k) application electronically through the FDA's Electronic Submission Gateway.
9. Pay the required user fee and retain proof of payment.
10. Monitor the submission status through the FDA's online portal and be prepared to respond to any inquiries.

Who needs S2000 Ultrasound System 510(k) Submission?

1. Manufacturers of the S2000 Ultrasound System who intend to market their device in the U.S.
2. Healthcare facilities seeking to purchase or use the S2000 Ultrasound System.
3. Regulatory affairs professionals involved in device submissions to the FDA.
4. Quality assurance personnel responsible for ensuring compliance with FDA regulations.

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 premarket notification process required by the FDA for medical devices, including ultrasound systems, to demonstrate that the device is safe and effective, and is substantially equivalent to a legally marketed device.

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

Manufacturers and importers of the S2000 Ultrasound System, or any company intending to market the device in the United States, are required to file a 510(k) submission.

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

To fill out the S2000 Ultrasound System 510(k) Submission, the applicant must complete the FDA’s 510(k) form, provide information about the device, including its intended use, description, labeling, and performance data, and include comparisons to predicate devices.

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

The purpose of the S2000 Ultrasound System 510(k) Submission is to provide the FDA with sufficient information to evaluate the device's safety and effectiveness and to ensure it meets regulatory requirements before being marketed in the U.S.

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

The information that must be reported includes the device's name and classification, intended use, device description, technological characteristics, performance testing results, labeling information, and substantial equivalence to predicate devices.