Colorado X-Ray Facility Guide: From First Question to Certified Operation

Contacts for VerificationBack to contents

The Cost of Non-Compliance - Understand The ProcessBack to contents

Skipping the shielding design or the certification evaluation is not a paperwork shortcut. Installing without a written shielding design from a Colorado-registered Qualified Expert violates Part 6, Section 6.3.2 (see Stage 3). Operating without the initial Qualified Inspector certification evaluation violates Part 2, Section 2.5.1.4 (see Stage 8). CDPHE can issue a cease-and-desist order, assess civil penalties, and pursue further enforcement. Civil penalties under Colorado Revised Statutes 25-5-1204 range from $1,000 to $10,000 per offense, collected through district court. Part 13 of the radiation control rules allows administrative penalties up to $15,000 per day per violation. Non-routine inspection fees are $152 per hour. A lapsed registration adds a $50 reinstatement fee under Part 12, Section 12.4.2.2. A documented violation also creates liability if a patient or staff member is harmed.

Stage 1: Clarify Clinical Need, Space, and Electrical CapacityBack to contents

Start with a Colorado-registered service company that can discuss equipment options for your specific diagnostic work, available space, electrical capacity, and budget. Most providers do not know their realistic options within their diagnostic needs, physical space, electrical service, and budget. A registered service company that works with your type of practice can walk through those constraints before any drawings or purchases are made. See how Fix My X-Ray helps and the specialties we support.

Confirm the company is registered for the type and brand of equipment under consideration. Verify the registration and approved categories on the current CDPHE spreadsheet at cdphe.colorado.gov/hm/xray-registration-verifications. Ask for a copy of the registration and confirm the technicians who will perform the work are listed.

Obtain the electrical requirements early: voltage, amperage, dedicated circuit size, and grounding. Many existing rooms require a service or breaker upgrade. Identifying this requirement before construction prevents later rework.

Stage 2: Define Room Requirements and Prepare the DrawingBack to contents

Once the equipment choice is clear, obtain the physical requirements from the same service company: footprint, ceiling height, operator position, cable paths, and primary beam directions. Use that information to confirm the space can support the system both physically and electrically.

Prepare a scaled room drawing for the Qualified Expert. The drawing must show overall dimensions, wall materials and thicknesses, adjacent spaces (including above and below), doors and windows, proposed equipment location and orientation, the operator’s normal position, and primary beam directions. This is the information required under Appendix 6A of Part 6.

Stage 3: Obtain the Written Shielding DesignBack to contents

Engage a Colorado-registered Qualified Expert authorized for your specific equipment type. Provide the scaled drawing and anticipated workload. The Qualified Expert produces the written shielding design (or a written exemption if one applies). For most stationary systems, Part 6, Section 6.3.2 requires the design to be completed before installation. Firms that hold the Colorado registration are listed on the shielding design and certification evaluation providers page.

The design must address the protected operator position and, when required, the operator’s booth and leaded viewing window consistent with Appendix 6B.

Retain the shielding design and dimensional drawing for the life of the facility. These documents form part of the permanent compliance file.

Stage 4: Construct and Electrically Prepare the SpaceBack to contents

Build according to the shielding design. No special contractor license is required to install shielding. Any general contractor or construction crew may perform the work provided they follow the Qualified Expert’s written design exactly—materials, thicknesses, placement, and the protected operator position. The finished construction must match the design on paper.

A licensed electrician installs the dedicated circuit. The facility must pass the local electrical inspection. Local building and electrical permits are separate from CDPHE rules.

The Qualified Inspector’s certification evaluation is what verifies the shielding performs as designed. If the finished construction does not match the design, walls may need to be reopened.

Stage 5: Designate the RSO, Confirm Operator Qualifications, and Establish MonitoringBack to contents

Designate the Radiation Safety Officer. The RSO must meet the qualifications in Appendix 2A of Part 2.

Confirm every operator meets the training and experience requirements in Part 2, Section 2.6.1, or holds the applicable certification or limited-scope registration. If limited-scope operators will be used, complete their registration before the first patient.

If personnel monitoring will be required under Part 4, Section 4.18 (fluoroscopy, CT, mobile X-ray, routine patient holding, or anyone likely to exceed 10 percent of the occupational dose limit), open an account with a monitoring company and order badges so they arrive before the first patient. Form R-4 asks for the monitoring company name and account number, so have the account open before submitting the registration.

Stage 6: Install, File Form 2579, and Handle Any DispositionBack to contents

Have the registered service company install the system. At completion they file FDA Form 2579 (Report of Assembly of a Diagnostic X-Ray System) and provide copies to you and to CDPHE. Keep the Form 2579 with the machine file.

If an old system is being removed, transferred, disposed of, or placed in storage, file Form R-61 (Disposition of Radiation Machines) or have the service company file it.

Stage 7: Register the FacilityBack to contents

Submit Form R-4 before the machine is used on patients. Part 2 requires registration before use. The form requires the RSO name and, when monitoring is used, the monitoring company and account number. An annual facility registration fee applies under Part 12, Category 26.

Stage 8: Certification Evaluation and Ongoing ComplianceBack to contents

Have a Colorado-registered Qualified Inspector perform the initial certification evaluation within 90 calendar days of installation, per Part 2, Section 2.5.1.4. Mammography and CT systems have additional prior-to-use requirements. Keep the report.

Subsequent evaluations follow Table 2-1: annual for most human-use systems; every three years for typical veterinary systems, podiatry systems used at 30 mA or less, and many dental systems.

Maintain the registration annually. Keep the shielding design, all evaluation reports, operator training records, and monitoring records on file.

Form R-65 (Notice of Registrant’s Rights) is required before the service or evaluation begins whenever a business relationship exists between the qualified inspector and a registered service company, or between a qualified expert and a qualified inspector.

Enforcement and PenaltiesBack to contents

Installing an X-ray system without a written shielding design from a Colorado-registered Qualified Expert is a violation of Part 6, Section 6.3.2. Operating without the initial Qualified Inspector certification evaluation is a separate violation of Part 2, Section 2.5.1.4. Any radiation machine or facility not inspected according to Sections 2.5.1.1 through 2.5.1.5, or otherwise determined to be out of compliance, is subject to Department enforcement.

CDPHE can issue a cease-and-desist order, assess civil penalties, and pursue further enforcement. Civil penalties under Colorado Revised Statutes 25-5-1204 range from $1,000 to $10,000 per offense, collected through district court. Part 13 of the radiation control rules allows administrative penalties up to $15,000 per day per violation. Non-routine inspection fees are $152 per hour. A lapsed registration adds a $50 reinstatement fee under Part 12, Section 12.4.2.2. A documented violation also creates liability if a patient or staff member is harmed.

GlossaryBack to contents

Qualified Expert (QE)Back to text

An individual registered with Colorado to design or evaluate protective shielding so that public and worker dose limits are met. For healing-arts equipment the designation is QE(R).

Qualified Inspector (QI)Back to text

An individual registered with Colorado to perform the official certification evaluation of a radiation machine. The QI does not install or repair the equipment unless that person also holds a separate registration to do so.

Form R-65 (Notice of Registrant’s Rights)Back to text

Required before the service or evaluation begins whenever a business relationship exists between the qualified inspector and a registered service company, or between a qualified expert and a qualified inspector. This covers the three situations in the regulation: when the qualified inspector is also registered to perform services and servicing, when the qualified inspector is also a qualified expert, and when the qualified inspector, qualified expert, and/or services-and-servicing provider are members of the same formal business entity.

Form R-4Back to text

Facility registration form. Required before the machine is used on patients.

Form 2579Back to text

FDA Report of Assembly of a Diagnostic X-Ray System. Filed by the registered service company at the end of installation. Copies go to the facility and CDPHE.

Form R-61Back to text

Disposition of Radiation Machines. Used to notify CDPHE when a machine is sold, transferred, disposed of, recycled, or placed in storage.

Radiation Safety Officer (RSO)Back to text

The individual designated on the facility registration who is responsible for radiation protection at the site. Must meet the qualifications in Appendix 2A.

Shielding DesignBack to text

The written plan produced by a Qualified Expert that specifies barrier materials, thicknesses, and layout needed to keep occupational and public doses within limits.

Frequently Asked Questions (FAQ)Back to contents

Bibliography and Official ResourcesBack to contents

• Colorado Rules and Regulations Pertaining to Radiation Control, 6 CCR 1007-1, Parts 2, 4, 6, 12, and 13. Official text is published by the Colorado Secretary of State Code of Colorado Regulations.
  • Part 2 — 6 CCR 1007-1
  • Part 4 — 6 CCR 1007-1
  • Part 6 — 6 CCR 1007-1
  • Part 12 — 6 CCR 1007-1
  • CDPHE radiation regulations collection
• Colorado Revised Statutes 25-5-1204 (civil penalties). Official statutes: leg.colorado.gov/colorado-revised-statutes.
• CDPHE X-Ray Registration Verifications: cdphe.colorado.gov/hm/xray-registration-verifications
• CDPHE X-Ray Machine Facilities Guidance: cdphe.colorado.gov/hm/xray-machine-facilities
• CDPHE X-Ray Forms and Guidance: cdphe.colorado.gov/hm/xray-guidance-and-policy