FDA X‑Ray Application Form – Fillable PDF

The FDA X‑Ray Application Form is the official document used to request approval for diagnostic X‑ray systems and related medical devices. This form must be completed accurately before the Food and Drug Administration (FDA) can evaluate your device for market clearance.

What Is the FDA X‑Ray Application Form?

The form, officially titled Report of Assembly of a Diagnostic X‑Ray System, collects detailed information about the device design, manufacturing, safety testing, and intended use. It is required for:

• New diagnostic X‑ray equipment submissions
• Major modifications to an existing X‑ray system
• Transfer of ownership or location

How to Fill the Form Online

Instead of downloading and editing the PDF in a separate editor, simply click the "Fill out this form" button on this page. The Formize PDF Filler app will load instantly, allowing you to:

1. Navigate each section with a clear sidebar.
2. Enter data directly into fillable fields.
3. Save your progress at any time.
4. Download the completed PDF for submission.

Common Mistakes & Tips

• Missing serial numbers: Every component must have a unique identifier.
• Incorrect units: Use the units specified in the instructions (e.g., kV, mA).
• Skipping optional fields: Even optional sections can provide valuable context for reviewers.
• Unclear signatures: Use the built‑in signature field; handwritten signatures are not accepted.

Submission Process & Requirements

After completing the form, follow these steps:

1. Download the filled PDF.
2. Attach the PDF to your electronic submission portal (e.g., FDA’s eSubmitter).
3. Include any required supporting documents such as test reports, labeling, and quality system certificates.
4. Pay the applicable FDA filing fee.
5. Track your submission status through the FDA’s online portal.

FAQs About the FDA X‑Ray Form

Below are the most frequently asked questions to help you complete the form with confidence.