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This page describes products and general use; it is not medical advice.
An x-ray equipment supplier is not one kind of company. Under US federal rules for diagnostic x-ray systems, the firm that makes a component, the firm that assembles and installs the system, and the dealer or distributor that sells it have different duties, and each duty leaves a document a buyer can ask for. Clinic managers, imaging buyers and students use this page to work out who is who and which records to request. It covers diagnostic medical x-ray equipment only, not industrial inspection systems, and it does not give prices (for those see x-ray machine cost).
What an x-ray equipment supplier is: manufacturer, assembler, dealer
A supplier of x-ray equipment can be a manufacturer, an assembler, or a dealer or distributor, and one company can hold more than one role. The roles matter because federal regulation assigns different obligations to each. For the wider distributor picture, see medical equipment distributor roles under FDA rules.
| Role | What the regulation says | Source |
|---|---|---|
| Manufacturer | Must certify that each product meets all applicable requirements when installed according to its instructions, and must permanently inscribe or affix the model number and serial number on components. It is not responsible for noncompliance caused solely by another person’s improper installation. | 21 CFR 1020.30(c), (e) |
| Assembler | Defined as any person engaged in the business of assembling, replacing, or installing one or more components into a diagnostic x-ray system or subsystem. Must assemble, install, adjust and test certified components according to the manufacturers’ instructions. | 21 CFR 1020.30(b), (d) |
| Dealer or distributor | Manufacturers, dealers and distributors of electronic products are all subject to the provisions of 21 CFR Part 1002. A manufacturer’s certification goes to the dealer or distributor at delivery. | 21 CFR 1002.1; 21 CFR 1010.2(a) |
Radiographic equipment is also a medical device, so it must additionally comply with the FDA medical device regulations, according to FDA’s radiography page.
How certification and assembly are documented
The certification label
Every manufacturer of an electronic product that has an applicable standard must certify it. The certification states that the product conforms to all applicable standards, and it takes the form of a label or tag permanently affixed to or inscribed on the product, in English (21 CFR 1010.2(a)-(b)). It must rest on a test in accordance with the standard, or on a testing program in accordance with good manufacturing practices (1010.2(c)).
The Report of Assembly (Form FDA 2579)
When an assembler installs certified components, it must affirm in a report that the manufacturers’ instructions were followed. The report is made on Form FDA 2579, and the completed report goes to the purchaser, and to the state radiation agency where applicable, within 15 days following completion of the assembly (21 CFR 1020.30(d)(1)). The regulation lists exceptions, including reinstalled or replacement tube housing assemblies, certified accessory components, and certain repairs or temporary replacements (1020.30(d)(2)). FDA’s footnote to Part 1002 also notes that a Report of Assembly is required for diagnostic x-ray components (21 CFR 1002.1).
Documents to request from an x-ray equipment supplier
The table lists records the regulation itself describes. Asking for them is a way to check that the supplier’s role matches what it is selling you.
| Document or marking | What it shows | Source |
|---|---|---|
| Certification label or tag on the product | The manufacturer’s statement that the product conforms to all applicable standards | 21 CFR 1010.2(a)-(b) |
| Model and serial number on each component | Which certified component you received; tube housing assemblies also show the manufacturer name and the x-ray tube model and serial number | 21 CFR 1020.30(e), (e)(1) |
| Report of Assembly, Form FDA 2579 | The assembler’s affirmation that the manufacturers’ instructions were followed, delivered to the purchaser within 15 days of completing assembly | 21 CFR 1020.30(d)(1) |
| Manual or instruction sheet, including radiological safety instructions and a maintenance schedule | Manufacturers must provide it to purchasers and, on request, to others | 21 CFR 1020.30(h)(1) |
| Tube housing data: leakage technique factors, cooling curves, tube rating charts | Operating limits of the tube housing assembly | 21 CFR 1020.30(h)(2) |
| Control and generator statements on line voltage, output and technique factors | The electrical conditions the control or generator is specified for | 21 CFR 1020.30(h)(3) |
How to compare suppliers
The regulation supplies the checks; it does not rank suppliers. Using only the criteria above:
- Identify which role the supplier holds for the item in front of you: manufacturer, assembler, or dealer.
- Confirm each certified component carries a certification label and a model and serial number.
- If the supplier assembles or installs, confirm that Form FDA 2579 will be delivered to you after assembly.
- Confirm the written manuals, with radiological safety instructions and a maintenance schedule, are supplied.
Quality-system certification of a manufacturer is a separate subject; see ISO 13485 certification.
Safe use and handling basics
The manufacturer’s radiological safety instructions are the primary reference for safe operation, and the regulation requires them to be part of the manual (21 CFR 1020.30(h)(1)). The manual’s maintenance schedule is the starting point for service planning; see biomedical equipment maintenance. Imaging accreditation is a separate topic, covered in ACR accreditation.
Common mistakes
- Treating a dealer as the manufacturer. Certification comes from the manufacturer; the dealer receives it at delivery.
- Not collecting Form FDA 2579 after an installation by an assembler. The regulation names the purchaser as the recipient.
- Assuming every replacement part triggers a new report. The regulation lists exceptions, such as reinstalled or replacement tube housing assemblies and certified accessory components.
- Applying this checklist to industrial inspection systems. This page covers diagnostic medical x-ray only.
FAQ
Who is responsible for certifying an x-ray system?
The manufacturer. Under 21 CFR 1020.30(c), manufacturers must certify that each of their products meets all applicable requirements when installed according to their instructions, using the format in 21 CFR 1010.2.
What is Form FDA 2579?
It is the Report of Assembly. An assembler uses it to affirm that the manufacturers’ instructions were followed, and the completed report goes to the purchaser within 15 days following completion of the assembly (21 CFR 1020.30(d)(1)).
What does an x-ray equipment supplier have to give the buyer?
Manufacturers must provide purchasers with manuals or instruction sheets that include radiological safety instructions and a maintenance schedule (21 CFR 1020.30(h)(1)), and certified components carry a certification label and model and serial numbers.
Does a dealer or distributor certify the equipment?
No. Dealers and distributors are subject to 21 CFR Part 1002, and the manufacturer’s certification is delivered to them at the time of delivery of the product (21 CFR 1002.1; 21 CFR 1010.2(a)).
Sources
Sources checked 2 November 2026.
- 21 CFR 1020.30, Diagnostic x-ray systems and their major components, law.cornell.edu/cfr/text/21/1020.30
- 21 CFR 1010.2, Certification, law.cornell.edu/cfr/text/21/1010.2
- 21 CFR 1002.1, Applicability (records and reports), law.cornell.edu/cfr/text/21/1002.1
- FDA, Radiography (page current as of 09/28/2020), www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/radiography
