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.
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:
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:
After completing the form, follow these steps:
Below are the most frequently asked questions to help you complete the form with confidence.
No. The Formize PDF Filler works entirely in your web browser, so no extra software is required.
Yes. Use the "Save Draft" button to download a partially completed PDF and reload it later in the Formize filler.
You can reopen the saved PDF in the Formize filler, correct the error, and re‑download the updated version.
Yes. The form includes a built‑in electronic signature field that complies with FDA requirements.
Review times vary by device complexity, but most diagnostic X‑ray submissions are processed within 60‑90 days after complete submission.
Yes. The FDA charges a filing fee based on the device classification. Check the FDA fee schedule for the exact amount.
The FDA’s website provides detailed guidance in the "Device Registration and Listing" section. Links are included on the form’s instruction page.
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