Get the free 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner - accessdata fda

This document provides a summary of the safety and effectiveness of the Ultrasonix Ergosonix 500 Ultrasound Scanner as part of the Premarket Notification, detailing device classification, intended

How to fill out 510 k summary for

How to fill out 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner

1. Start by obtaining the FDA's 510(k) submission guidelines.
2. Gather information about the Ultrasonix Ergosonix 500 Ultrasound Scanner, including its intended use and technology.
3. Provide a description of the device, including specifications and performance characteristics.
4. Identify the predicate device(s) that your scanner is comparable to and justify your selection.
5. Conduct non-clinical and clinical testing and summarize the results.
6. Complete the 510(k) cover sheet and fill in all required forms accurately.
7. Review and compile supporting documentation, including labeling and shelf-life studies.
8. Create a table of contents to ensure all information is organized.
9. Submit the completed 510(k) application to the FDA, along with the required fee.

Who needs 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner?

1. Manufacturers of the Ultrasonix Ergosonix 500 Ultrasound Scanner who want to market the device.
2. Regulatory affairs professionals working on obtaining FDA clearance.
3. Quality assurance teams who are ensuring compliance with FDA regulations.
4. Healthcare facilities planning to purchase the device for use in medical diagnostics.

People Also Ask about

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is 510 K to the FDA?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What is the 510k approval process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What are the 5 phases of the medical device development process?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

How long does it take for 510K approval?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

What is the rejection rate for 510K?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

What is the 510k FDA summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is the 5 10k approval process?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

How long does 510 K clearance take?

Information For Step 1: Device Discovery and Concept. Step 2: Preclinical Research-Prototype. Step 3: Pathway to Approval. Step 4: FDA Device Review. Step 5: FDA Post-Market Device Safety Monitoring.

How long does it take to get a 510 K approval?

The FDA has 90 days to review a traditional 510(k), but the timeline can vary from three to eight months depending on additional information requests and other factors.

For pdfFiller’s FAQs

What is 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner?

The 510(k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner is a document submitted to the FDA that demonstrates the device is substantially equivalent to a legally marketed device. It includes information on the device's intended use, technological characteristics, and performance data.

Who is required to file 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner?

The manufacturer or importer of the Ultrasonix Ergosonix 500 Ultrasound Scanner is required to file the 510(k) Summary with the FDA before marketing the device.

How to fill out 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner?

To fill out the 510(k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner, the filer needs to provide details such as the device name, intended use, description, comparison to predicate devices, and any clinical or non-clinical data supporting safety and effectiveness.

What is the purpose of 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner?

The purpose of the 510(k) Summary is to ensure that the Ultrasonix Ergosonix 500 Ultrasound Scanner is safe and effective for its intended use, and to allow for regulatory review of its specifications and performance in relation to existing devices.

What information must be reported on 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner?

The information that must be reported includes the device identification, manufacturer's details, a description of the device, intended use, summary of technological characteristics, and any clinical data if applicable, alongside a comparison with predicates.