Home
Forms Library
Summary of Safety and Effectiveness - gov fda accessdata www - accessdata fda

Summary of Safety and Effectiveness - gov fda accessdata www - accessdata fda 2025

Summary of Safety and Effectiveness - gov fda accessdata www - accessdata fda Preview on Page 1

Show details

4 out of 5

52 votes

The document is a 510(k) premarket notification for the SonoSite Hand-Carried Ultrasound System (Cl Series), submitted by SonoSite, Inc. It outlines the device's safety and effectiveness, including its intended use for diagnostic ultrasound imaging of small organs such as the breast, thyroid, testicles, and prostate. The submission adds this new clinical application to previously cleared indications without any technological changes. The document also details compliance with various FDA standards and concludes that the device is substantially equivalent to a predicate device.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

The best way to modify Summary of Safety and Effectiveness - gov fda accessdata www - accessdata fda online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

With DocHub, making changes to your paperwork requires only a few simple clicks. Make these quick steps to modify the PDF Summary of Safety and Effectiveness - gov fda accessdata www - accessdata fda online free of charge:

Register and log in to your account. Log in to the editor with your credentials or click on Create free account to test the tool’s capabilities.
Add the Summary of Safety and Effectiveness - gov fda accessdata www - accessdata fda for editing. Click the New Document option above, then drag and drop the document to the upload area, import it from the cloud, or using a link.
Adjust your file. Make any changes required: insert text and images to your Summary of Safety and Effectiveness - gov fda accessdata www - accessdata fda, highlight information that matters, remove sections of content and replace them with new ones, and add symbols, checkmarks, and fields for filling out.
Complete redacting the form. Save the updated document on your device, export it to the cloud, print it right from the editor, or share it with all the people involved.

Our editor is super user-friendly and effective. Try it now!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

How does the FDA ensure drug safety?

The FDA approval process requires comprehensive pre-clinical testing followed by multi-phase clinical trials to ensure safety and efficacy.

How does the FDA ensure the safety and effectiveness of drugs?

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

How does the FDA ensure that over the counter drugs are safe and effective?

To further ensure the safe use of OTC products, FDA conducts studies to learn if potential OTC consumers understand the Drug Facts label, can properly choose the medicine for their needs, and use it ing to the directions.

What is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices?

FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself.

What is 510k summary of safety and effectiveness?

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) FDC Act).