It’s a scenario that plays out in dental offices more often than you’d think. A physicist or inspector arrives to evaluate your X-ray system, looks around, and suddenly asks, “Can I see your FDA Form 2579?”
You search your files and wonder where it’s supposed to be—or what it even is. The initials “FDA” alone are enough to cause a ripple of anxiety, but in reality, the situation is easy to resolve once you understand what the form is, why it exists, and how it fits into your office’s compliance obligations.
Let’s break down what every dental professional should know about the FDA 2579 form—how to get it, what it verifies, and why keeping it on file is essential for your practice.
What Is the FDA 2579 Form?
The FDA 2579 form is officially titled the Report of Assembly of a Diagnostic X-Ray System. It’s required under federal law by the U.S. Food and Drug Administration (FDA)—specifically, by the Center for Devices and Radiological Health (CDRH).
In plain terms, the form documents that any X-ray–emitting equipment in your facility—such as a panoramic X-ray, cone beam CT (CBCT), or intraoral system—was installed according to the manufacturer’s specifications and is operating safely.
Whenever a new X-ray system or a major component is installed, repaired, or upgraded, the installing engineer (referred to by the FDA as the “assembler”) must complete and submit this form. By signing it, the assembler certifies that:
The equipment was assembled per manufacturer guidelines.
All safety features, such as exposure controls, warning lights, and shielding, were installed and tested.
The system meets federal radiation safety performance standards.
This form is part of the FDA’s effort to ensure patient and operator safety under the Radiation Control for Health and Safety Act of 1968.
When Is a 2579 Required?
It’s not only for brand-new system installations. A 2579 must also be completed any time an X-ray–emitting component is replaced or added, including:
Tubehead replacements or generator swaps
Major control board or power supply replacements
Digital detector or sensor upgrades
Field conversions (for example, upgrading a panoramic to a cone beam unit)
In short, any assembly that could affect radiation output or performance requires a new form.
Who Fills Out the Form?
The form must be completed and signed by the installer or service engineer who assembled or reassembled the device. In most states, that individual must also be registered or licensed with the state’s radiological health department.
Reputable manufacturers and service providers—such as your dental imaging supplier—should always provide and file this form as part of every installation or major service event. If an installer seems unfamiliar with it, that’s a red flag that they may not be authorized to perform X-ray work in your state.
How the 2579 Is Filed and Distributed
Once completed, the form is distributed in four color-coded copies:
White (Original): Sent to the FDA
Yellow: Sent to the state’s radiological health department
Pink: Left onsite with the dental practice (your copy)
Blue: Retained by the installer
Each form carries a unique serial number tied to your specific installation and cannot be reused. The pink copy should be filed in your office’s compliance or equipment records, ideally alongside your physicist’s shielding report and any local radiation registration documents.
Where to Get the FDA 2579 Form
Your installer should always bring the form when setting up or upgrading your imaging system. However, if they do not have one—or you need a replacement—you can request it directly from the FDA:
👉 FDA Request for 2579 Forms: https://www.fda.gov/radiation-emitting-products
Many imaging manufacturers and distributors (including ImageWorks) can also provide blank forms and guidance if needed.
Why You Must Keep a Copy Onsite
There are three key reasons every dental office should keep its 2579 readily available:
It’s a legal requirement.
Federal and state regulations mandate that the form be completed and accessible for inspection.It’s proof of compliance.
During accreditation reviews or inspections, physicists and health department officials often request to see your 2579. Having it ready demonstrates that your imaging systems were installed properly.It protects your practice.
If an incident ever occurs involving an X-ray system—such as an injury or a malfunction—the 2579 provides official documentation that your equipment was installed according to specifications.
Staying Audit-Ready
A good best practice is to maintain an “Imaging Compliance Binder” that includes:
The FDA 2579 form(s) for each imaging system
The most recent shielding design and physicist report
State registration or radiation license documentation
Any service records or upgrade forms that affected X-ray components
Keeping these records organized makes inspections straightforward and shows that your office takes radiation safety seriously.
Partnering With the Right Installer
Because the 2579 form reflects both installation quality and regulatory compliance, it’s critical to work with installers who understand and follow these standards. A qualified dental imaging partner will:
Handle the 2579 form automatically as part of every installation.
Ensure that all radiation-emitting components are properly registered with your state.
Provide support if your physicist or inspector ever requests documentation.
If your vendor can’t provide a copy of your 2579, or if you’re unsure whether a recent upgrade was documented, contact them—or your state radiological health department—to confirm.
Conclusion
The FDA 2579 form may seem like a small piece of paperwork, but it plays a crucial role in ensuring that your imaging systems are safe, compliant, and properly documented. Understanding what it is—and keeping your copy on file—protects your patients, your team, and your practice.
When it comes to compliance, preparation is the best form of protection.
About ImageWorks
At ImageWorks, we believe dentists deserve imaging technology that delivers exceptional image quality, fair pricing, and dependable performance—without the headaches. Our panoramic, cone beam, and intraoral imaging systems are designed to give you crystal-clear diagnostics while keeping ownership simple and affordable.