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This document provides a summary of the premarket notification for the SR Suite 1.0, a stationary digital x-ray system intended for general radiography and RSA procedures, outlining its identification,

How to fill out 510k summary k121345

How to fill out 510(k) Summary K121345

1. Identify the device that you are submitting for 510(k) clearance.
2. Gather all necessary information about the device, including its intended use, safety, and effectiveness.
3. Provide a detailed description of the device, including its components, materials, and specifications.
4. Identify and discuss substantial equivalence to a legally marketed device.
5. Conduct and document any required performance testing or clinical studies.
6. Include labeling and promotional materials for the device.
7. Compile a summary of the device's technological characteristics.
8. Prepare the 510(k) submission, ensuring all formatting and content guidelines are followed.
9. Submit the application to the FDA, including any required fees.

Who needs 510(k) Summary K121345?

1. Manufacturers who intend to market a medical device that is similar to an existing device.
2. Companies looking to demonstrate that their device is safe and effective for its intended use.
3. Businesses requiring FDA clearance before commercializing their medical device.

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 the 510k clearance process?

The 510k clearance process is the most common pre-market pathway used by medical device companies to legally sell products in the US, as data from the FDA shows that: 35% of medical devices are in Class I, the lowest risk class, as they present minimal potential for harm to the end user.

How long will it take my 510 K to be cleared by the US FDA?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

How to look up a 510k?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the 510k summary?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is 510k summary report?

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) that is not subject to premarket approval.

What is 501k approval?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

For pdfFiller’s FAQs

What is 510(k) Summary K121345?

510(k) Summary K121345 is a premarket submission made to the FDA by a medical device manufacturer to demonstrate that a device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary K121345?

Manufacturers of medical devices that are seeking to obtain clearance to market their devices in the United States are required to file a 510(k) Summary K121345.

How to fill out 510(k) Summary K121345?

To fill out 510(k) Summary K121345, manufacturers must provide detailed information including device description, intended use, labeling, and performance data that demonstrate substantial equivalence to a predicate device.

What is the purpose of 510(k) Summary K121345?

The purpose of 510(k) Summary K121345 is to allow the FDA to assess whether the new device is as safe and effective as an already legally marketed device, ensuring patient safety and regulatory compliance.

What information must be reported on 510(k) Summary K121345?

The information that must be reported on 510(k) Summary K121345 includes the device name, manufacturer details, a description of the device, intended use, technological characteristics, and any supporting data demonstrating substantial equivalence.