Get the free 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 - acces...
Show details
This document provides a summary of a premarket notification (510(k)) submission to the FDA for three models of computed tomography X-ray systems, detailing their intended use, technological characteristics,
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign 510k summary for synerad
Edit your 510k summary for synerad form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your 510k summary for synerad form via URL. You can also download, print, or export forms to your preferred cloud storage service.
Editing 510k summary for synerad online
To use the services of a skilled PDF editor, follow these steps below:
1
Log in to account. Start Free Trial and register a profile if you don't have one.
2
Upload a document. Select Add New on your Dashboard and transfer a file into the system in one of the following ways: by uploading it from your device or importing from the cloud, web, or internal mail. Then, click Start editing.
3
Edit 510k summary for synerad. Rearrange and rotate pages, add new and changed texts, add new objects, and use other useful tools. When you're done, click Done. You can use the Documents tab to merge, split, lock, or unlock your files.
4
Get your file. When you find your file in the docs list, click on its name and choose how you want to save it. To get the PDF, you can save it, send an email with it, or move it to the cloud.
With pdfFiller, it's always easy to work with documents. Check it out!
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out 510k summary for synerad
How to fill out 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600
01
Gather product information including intended use, technological characteristics, and summary of non-clinical and clinical data.
02
Identify the predicate device to which your device is claiming substantial equivalence.
03
Prepare a detailed description of the device including its components and materials used.
04
Document any arguments supporting the safety and effectiveness of your device based on the predicate.
05
Include any testing data or results from non-clinical and clinical evaluations that may be relevant.
06
Organize the summary to clearly present the information in a logical and concise manner, addressing FDA requirements.
07
Review and edit the summary for completeness and accuracy before submission.
Who needs 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600?
01
Manufacturers of SyneRad IMPACT 60, SyneRad IMPACT 72, and Analogic AMS1600 who intend to market these devices in the United States.
02
Importers and distributors of these medical devices who require regulatory clearance from the FDA.
Fill
form
: Try Risk Free
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600?
The 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72, and Analogic AMS1600 is a document submitted to the FDA that includes information about the devices, including their intended use, technological characteristics, and comparisons to predicate devices. This summary facilitates the FDA's determination on whether the devices are safe and effective.
Who is required to file 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600?
Manufacturers of SyneRad IMPACT 60, SyneRad IMPACT 72, and Analogic AMS1600, or authorized representatives acting on their behalf, are required to file the 510(k) Summary with the FDA before marketing these devices.
How to fill out 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600?
To fill out the 510(k) Summary, manufacturers must provide specific information including device name, intended use, description of the device, labeling, and performance data. Instructions and templates provided by the FDA should be followed to ensure compliance with their requirements.
What is the purpose of 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600?
The purpose of the 510(k) Summary is to demonstrate to the FDA that the devices are substantially equivalent to a legally marketed predicate device. This is a necessary step for obtaining clearance to market the devices in the United States.
What information must be reported on 510(k) Summary for SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600?
The information required in the 510(k) Summary includes the device name, identification of the predicate device, a description of the device, intended use, labeling, performance testing results, and standards met by the device.
Fill out your 510k summary for synerad online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
510k Summary For Synerad is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
