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This document outlines the pre-market notification for the Vantage Titan HSR MRI system, detailing device specifications, establishment registration, FDA regulatory compliance, imaging performance

How to fill out pre-market notification 510k vantage

How to fill out Pre-Market Notification 510(k) Vantage Titan HSR

1. Gather the necessary documents, including device description, intended use, and proposed labeling.
2. Conduct a non-clinical and clinical testing analysis, if required.
3. Prepare a substantial equivalence comparison table showing your device and the predicate device.
4. Complete the FDA Form 3514 (for 510(k) submissions) accurately.
5. Compile any necessary risk analysis and manufacturing process details.
6. Pay the required user fee for the 510(k) submission.
7. Submit the completed Pre-Market Notification 510(k) through the FDA's electronic submission process.
8. Await FDA clearance and be prepared to respond to any additional requests for information.

Who needs Pre-Market Notification 510(k) Vantage Titan HSR?

1. Manufacturers of medical devices that intend to market a new device that is substantially equivalent to an already marketed device.
2. Companies looking to bring innovative medical products like the Vantage Titan HSR to the market after ensuring compliance with FDA regulations.

People Also Ask about

What is an exemption from the 510k premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is a 510 K premarket notification?

On the path to market, a granted de novo request has roughly the same weight as a “cleared” 510(k) submission. Both mean that FDA has opened the door to the market. FDA Approved: This term is reserved for the highest risk “Pre market approval” or PMA devices.

What is the meaning of premarket approval?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

How long does it take for the 510 K determination in the case of traditional premarket notification?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is premarket notification 510k?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

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What is Pre-Market Notification 510(k) Vantage Titan HSR?

Pre-Market Notification 510(k) Vantage Titan HSR is a submission process to the FDA that allows medical device manufacturers to demonstrate that their device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file Pre-Market Notification 510(k) Vantage Titan HSR?

Manufacturers of medical devices who intend to market their device in the United States are required to file a Pre-Market Notification 510(k) if their device is not exempt from this requirement. This applies to both domestic and foreign manufacturers.

How to fill out Pre-Market Notification 510(k) Vantage Titan HSR?

To fill out a Pre-Market Notification 510(k), manufacturers must provide a variety of information including the device name, intended use, description, significant risks, substantial equivalence information, and any necessary labeling or promotional material.

What is the purpose of Pre-Market Notification 510(k) Vantage Titan HSR?

The purpose of the Pre-Market Notification 510(k) is to allow the FDA to determine whether a medical device is substantially equivalent to a device that is already legally marketed, thereby ensuring its safety and effectiveness before it reaches the market.

What information must be reported on Pre-Market Notification 510(k) Vantage Titan HSR?

Information that must be reported includes device identification, device description, the intended use of the device, clinical and non-clinical data, proposed labeling, and any previous submissions relating to the device.