Get the free 510(k) Summary for TouchPACS Suite - accessdata fda

Submission of a 510(k) premarket notification for the TouchPACS Suite, which is a picture archiving and communications system (PACS) intended for medical imaging data management.

How to fill out 510k summary for touchpacs

How to fill out 510(k) Summary for TouchPACS Suite

1. Gather product information: Include the name, model, and intended use of TouchPACS Suite.
2. Identify predicate devices: List similar devices that have previously received 510(k) clearance and provide their K-number.
3. Describe technological characteristics: Outline the design, features, and specifications of TouchPACS Suite.
4. Perform risk analysis: Assess potential risks associated with the device and how they are mitigated.
5. Provide performance data: Include results from bench testing, software validation, and clinical data if applicable.
6. Compile labeling information: Provide sample labels, instructions for use, and marketing materials.
7. Complete the 510(k) form: Fill out the FDA's 510(k) application form with the collected information.
8. Submit the summary: Electronically submit the completed 510(k) Summary to the FDA along with any required fees.

Who needs 510(k) Summary for TouchPACS Suite?

1. Manufacturers of TouchPACS Suite that intend to market the product in the United States.
2. Importers who need to ensure compliance with FDA regulations for the device.
3. Healthcare providers and institutions seeking to understand the device's regulatory status.

People Also Ask about

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.

What is the 510k executive summary?

FDA 510k Executive Summary A 510k Summary provides a brief summary of the device included in the premarket notification and the supporting information. It must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

What is the 510k clearance process?

A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same level of risks, a CE Mark is required to market a medical device in the European Economic area.

What is a 510k executive summary?

FDA 510k Executive Summary A 510k Summary provides a brief summary of the device included in the premarket notification and the supporting information. It must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

What are the three types of 510k?

If so, then the 510(k) pathway is not appropriate, and instead, a De Novo or PMA is needed. There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices.

What is the difference between 510k and FDA approval?

The purpose of a 510(k) submission is to prove that your device is safe and effective by comparing it to a similar, legally marketed device—what the FDA calls a “predicate device.” If your 510(k) submission is approved, your product has earned FDA clearance, and you can legally market it.

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.

For pdfFiller’s FAQs

What is 510(k) Summary for TouchPACS Suite?

The 510(k) Summary for TouchPACS Suite is a document submitted to the FDA to demonstrate that the software is safe and effective for its intended use and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for TouchPACS Suite?

Manufacturers or importers of the TouchPACS Suite who wish to market the device in the United States are required to file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary for TouchPACS Suite?

To fill out the 510(k) Summary, manufacturers must provide information including device description, intended use, technological characteristics, performance testing data, and comparisons to predicate devices.

What is the purpose of 510(k) Summary for TouchPACS Suite?

The purpose of the 510(k) Summary for TouchPACS Suite is to inform the FDA about the device's safety and effectiveness relative to similar existing devices, ensuring it meets regulatory standards.

What information must be reported on 510(k) Summary for TouchPACS Suite?

The information that must be reported includes the device name, regulation number, contact information, description of the device, indications for use, summary of technological characteristics, and any clinical or non-clinical data supporting safety and effectiveness.