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X-ray sales or service company requirements

Registration of sales or service companies

  • Part 2: Section 2.4.2
    • Each sales or service company must complete the Service Company Application (Form R-60) for registration, pay the required processing fees, and obtain registration approval before performing sales or service.  
    • Each sales or service company must notify the department of any changes, including ownership, address, phone number, email, technician updates, or scope of practice.
    • Submit the annual non-refundable $100 application processing fee and, if applicable, a $60 fee for adding service technicians outside the renewal period.
    • Sales and service registration remains valid for one (1) year.


Service technician education and training

  • Part 2, Appendix 2H, Sections 2H.1 and 2H.2
    • Any individual who assembles, installs, or services x-ray machines must meet the following educational and experience requirements.
    • Complete a structured educational program covering radiation machine safety, assembly, installation, and service. Acceptable education includes, but is not limited to:
    • A baccalaureate degree in electrical engineering or related field with specialized training in radiation-producing machines.
    • A one-year associate degree in biomedical equipment repair or a similar field.
      • Equivalent training from a manufacturer, military program, or technical school.
    • In addition, for each service category requested education and training is required:
    • Service categories include: healing arts, dental, mammography, clinical radiation therapy, analytical, and industrial.
    • For each category the service technician must have a minimum of six (6) months of supervised, documented training on assembly, installation, and service in the applicable radiation machine category.
    • Servicing of mammography machines requires documented education and training specifically in mammography.

Service technician testing

  • Part 2, Section 2.4.2.3 (2)(b)
    • Management must attest that each service technician has been instructed in, and demonstrates an understanding of the following requirements:
    • Colorado regulations. Completing the service technician test with a passing score of 75% or higher adequately demonstrates this requirement.
    • The Federal Performance Standard (21 CFR Chapter I, Subchapter J).

Registration renewal requirement

  • Part 2, Section 2.4.2
    • Registrants must renew their registration annually by submitting the Service Company Application (Form R-60) and paying the required processing fees. Service technicians are included in this process.
    • To add service technicians outside the renewal period, submit a Service Company Application (Form R-60), complete testing, and pay a $60 processing fee. 

Sales or service company - application process

Submit R-60 service company application

 

New sales company registration

  • Sales only.
    • Complete the Service Company Application (Form R-60).
    • Pay the non-refundable $100 application processing fee.
    • Once approved, we will email you your registration, which is valid for one year.
    • After application approval, the invoice for new sales companies is emailed to the company contact.

New service company registration

  • Service.
    • Complete the Service Company Application (Form R-60).
    • Provide attestation or documentation for each new service technician added to the registration confirming education and experience.
    • Pay the non-refundable $100 processing fee.
    • After application approval, the invoice for new service companies is emailed to the company contact.
      • Service company documentation.
        • Attestation personnel dosimetry monitoring complies with Part 4, Sections 4.17 and 4.18.
        • Documentation or attestation confirming all calibration and testing instruments are adequate to ensure machine performance and compliance with manufacturer specifications.
        • Adding service technicians.
          • On the application, provide an attestation confirming each service technician being added to the registration has the required education and experience.
          • To demonstrate an understanding of the State of Colorado Radiation regulations, service technicians must complete the online test with a score of 75% or higher. Service technician test
          • The appointed official or primary contact of the service company must compile the test results and testing dates, then include this information in the application.
          • If adding technicians to service mammography units, include documentation of training certificates (or equivalent). This training must be specific to mammography machines to verify educational and/or clinical experience.
      • Payment.
        • A non-refundable $100 application processing fee applies to new applications.
        • A non-refundable $60 application processing fee is applicable when adding new technicians outside the annual renewal period.
        • After submitting your application, refer to the email from the X-ray Certification Unit for payment instructions.  
        • Once approved, we will email you your registration, which is valid for one year.

Renew sales or service company registration

  • Complete the Service Company Application (Form R-60) using the link above.
  • List all renewing service technicians on the application form. Technicians not listed on the renewal form will be removed from your registration.
  • Add any new service technicians to your renewal application (if applicable). Provide attestation or documentation for each new service technician added to the registration confirming education and experience. Each new service technician must complete the online test with a score of 75% or higher. Service technician test.
  • After application approval, the invoice for new service companies is emailed to the company contact.
  • Payment.
    • A non-refundable $100 application processing fee applies to renewal applications.
    • An invoice is mailed 60 days before your current registration expires to the mailing address listed on your registration.
    • Provide a copy of your payment receipt or check to confirm your current invoice is paid. To request a copy of your invoice please email: cdphe_xray_qisc@state.co.us.
    • Once approved, we will email you your registration, which is valid for one year.

Adding service technicians outside of the renewal period

  • A non-refundable $60 application processing fee applies when adding new technicians outside the annual renewal period.
  • Adding service technicians outside the renewal period requires submitting a new Service Company Application (Form R-60), completing technician testing, and paying a $60 processing fee.

Service company - frequently asked questions

How do I add service technicians to my registration? 

  • To add a new service technician, the service company must complete the Service Company Application (Form R-60). The technician must have at least six months of qualifying training, education, and experience. The service company may attest to the technician’s training and education, except for mammography technicians, who require additional documentation. All technicians must demonstrate an understanding of the Colorado Radiation Regulations and Federal rules (21 CFR). If adding technicians outside the renewal period, a $60 processing fee applies. An invoice will be emailed after submitting the application.

How does a service technician demonstrate an understanding of the Colorado Radiation Regulations?

  • Service technicians who have met the required education, training and six months of experience can take an online test. To demonstrate their understanding of the State of Colorado Radiation regulations, they must complete the online test with a score of 75% or higher. Test content is provided and may be referenced while taking the test. Service technician test

Can a service company also perform Qualified Inspector (QI) certification evaluations? 

  • Yes, but the individual performing the evaluation must have a current registration as a Colorado Qualified Inspector (QI). Before providing any service, the facility must receive a copy of the R-65 Notice of Registrant's Rights. R-65 Notice of Registrant's Rights  

As a service company, how do I provide a 2579 or equivalent machine notification to the state?

  • On the service company main page, you'll find a link for the CDPHE-Form 2579.  This form, or an equivalent notification form/letter can be used to report a machine installation or any other qualifying service to the state. The FDA 2579 Form may also be used to notify the state a machine's installation or service. Email notification forms to: cdphe_xray_qisc@state.co.us

What are the requirements for bringing an x-ray unit into Colorado on a short-term basis? For example, a loan, lease, machine demonstration or a temporary replacement?

  • For x-ray units operating in Colorado for less than 180 days in a calendar year, the service company completes the R-200 X-ray Reciprocity Form and submits it to the Colorado X-Ray Certification Unit. Notify the unit at least 15 days before bringing the x-ray machine into Colorado. Email R-200 forms to: cdphe_xray_qisc@state.co.us  The x-ray facility must also maintain a copy of the approval for compliance records. R-200 X-Ray Reciprocity Form

What are the requirements for removing, disabling or decommissioning an x-ray machine from a facility in Colorado?

  • A service company must remove or disable the x-ray unit. When doing so, the service company must either submit or instruct the facility to submit the R-61 Removal of a Radiation Machine Form to the X-Ray Certification Unit.  R-61 Removal of x-ray machine

Can any x-ray unit be sold or serviced in Colorado?

  • No. X-ray units must comply with FDA or other recognized performance standards to ensure radiation safety. Units that do not meet these standards could emit dangerous levels of radiation and pose other safety risks, especially for human imaging.
  • Do not purchase x-ray units from unregistered service companies, overseas manufacturers, or distributors. X-ray units sold online by manufacturers outside the United States and shipped directly to U.S. customers may lack proper clearance and fail to meet U.S. radiation safety requirements.

Can I buy an x-ray machine on eBay, Amazon, Alibaba or other online marketplace who is not registered in Colorado?

  • No, any person or company selling x-ray machines in Colorado must register with the state to provide sales and services. X-ray facilities must verify they are working with a registered service company when purchasing or requesting services x-ray machines. A list of registered service companies is available on our website for verification. X-ray registration verification  
  • I did not receive an invoice in the mail. How do I request an invoice? 
    Please contact the X-ray Certification Unit by email to request a copy of your invoice:  cdphe_xray_qisc@state.co.us. Please provide your service company name and registration number in your request.

 

Who needs to register as a service company in Colorado? 

  • A person or company that sells, leases, transfers, lends, assembles, installs, maintains, repairs, stores, trades out, disables or disposes of radiation machines and their related components, must register with the Colorado Department of Public Health and Environment (CDPHE) before performing these activities. Additionally, anyone furnishing or offering radiation machine servicing or services in Colorado must also register.

How do we become a registered service company in Colorado?

  • To register as a service company in Colorado, follow these steps:
    • Complete the Service Company Application (Form R-60).
    • Pay the non-refundable $100 application processing fee.
    • Include documentation for each service technician, confirming their required education, training, and experience.
    • Ensure service technicians complete the online test with a passing score of 75% or higher to demonstrate their understanding of Colorado Radiation Regulations.
    • Submit the application to the Colorado X-Ray Certification Unit for review.

Once approved, an invoice will be emailed, and the registration will be valid for one year.

How long is a sales or service registration valid?  

  • A service company registration is valid for one year. All sales and service companies must apply for annual renewal to continue offering service in Colorado.  

Can I add service technicians to my service company registration at any time?

  • Yes, you can add service technicians at any time. However, if adding technicians outside of the renewal period, you must:
    • Submit a new Service Company Application (Form R-60)
    • Ensure new technicians complete technician testing
    • Pay a $60 processing fee. After application approval, the invoice for new service technicians is emailed to the company contact.

Do x-ray machines for human imaging need FDA approval to be sold in Colorado?

  • Yes. To register as a service company selling x-ray machines for human imaging in Colorado, the machines must have FDA 510(k) clearance. During registration, you may be required to provide documentation of your 510(k) approval letter to verify that the machines have marketing clearance in the United States.

When can I renew my service company registration?

  • You can submit a registration renewal application thirty (30) days before the expiration date.  Applications will not be approved without a complete application and confirmation of payment.

I did not receive an invoice in the mail. How do I request an invoice? 

  • Please contact the X-ray Certification Unit by email to request a copy of your invoice:  cdphe_xray_qisc@state.co.us. Please provide your service company name and registration number in your request.

What happens if someone buys or acquires my service company or other account information changes? Are we required to notify you? 

  • Yes, you must notify us of any ownership changes or other updates, such as a change in address, phone number, billing, or contact information. Submit written notification via email to cdphe_xray_qisc@state.co.us as soon as possible.  

Do I need to renew service technicians? 

  • Yes. On the Service Company Application (Form R-60) list all renewing service technicians. Technicians not listed on the renewal form will be removed from your registration.

How will I know when it is time for me to renew my registration?

  • Your annual renewal application will be due thirty (30) days prior to your registration expiration date. You will receive a reminder email from the department.

For additional information

Please contact CDPHE X-ray Certification Unit at: cdphe_xray_qisc@state.co.us or call 303-692-3448.