X-ray Machines

X-ray Machines

Federal
U.S. Food & Drug Administration
7920 Elmbrook Dr. #102
DALLAS , TX   75247
(214)253-4952
(214)655-8100
Regulates manufacturing of diagnostic medical equipment and other radiation emitting products.

Link:  http://www.fda.gov/cdrh/devadvice/

State
Colorado Department of Public Health & Environment
Hazardous Materials & Waste Management Division
4300 Cherry Creek Drive South
Denver , CO   80246-1530
(303)692-3300
Fax: (303)759-5355
X-Ray facilities must be registered with the Division prior to operation.

Link:  http://www.cdphe.state.co.us/hm/rad/xray/xray.asp

Mammography inspections are performed annually based on federal Food ad Drug Administration (FDA) requirements, known as the Mammography Quality Standards Act (MQSA).

Link:  http://www.fda.gov/cdrh/mammography/guidance-docs.html

All x-ray machines must be registered with the division.
All new x-ray machines must be inspected by a qualified x-ray inspector within 90 days of installation.
All x-ray machines must be inspected on the following schedule by a qualified inspector: Annually: hospitals, chiropractors, MDs and DOs. Every 2 years: industrial users (airports) Every 3 years: Dentists, Podiatrists, and Veterinarians. Qualified Inspector certification obtained from the division. $50/yr. fee. The division maintains lists of qualified inspectors for distribution.
All x-ray service companies must also be registered with the CDPHE with an annual fee of $50.
State
Colorado Department of Public Health & Environment
Health Facilities Division
4300 Cherry Creek Drive South
Denver , CO   80246-1530
(303)692-2800
A portable diagnostic X-ray supplier must be registered with the Health Facilities Division. Tests must be under the supervision of a physician.

Link:  http://www.cdphe.state.co.us/hf/static/xray.htm

State
Colorado Division of Registrations
State Board of Medical Examiners
1560 Broadway #1300
Denver , CO   80202
(303)894-7690
Fax: (303)894-7692
X-Ray Technicians are not licensed by the State. However, persons not possessing a medical license who operate machine sources of ionizing radiation or who administer such radiation to patients for diagnostic medical use, outside of a hospital setting, must demonstrate competency via satisfactory passage of the limited scope examination administered by The American Registry of Radiologic Technologists (“ARRT”).

Link:  http://www.dora.state.co.us/medical/main-x-ray.htm

Unlicensed personnel administering x-rays in other professions (dental, veterinary, etc.) must meet training, supervision, and reporting requirements of the appropriate examining boards.

NOTE:  See MANUFACTURING regarding applicable environmental regulations.
NOTE:  If appropriate, see MEDICAL EQUIPMENT (manufacturing or importing).
NOTE:  See RADIOGRAPHER for non-medical Radiography.

X-ray Machines

|
Federal
U.S. Food & Drug Administration
7920 Elmbrook Dr. #102
DALLAS , TX   75247
(214)253-4952
(214)655-8100
Regulates manufacturing of diagnostic medical equipment and other radiation emitting products.

Link:  http://www.fda.gov/cdrh/devadvice/

State
Colorado Department of Public Health & Environment
Hazardous Materials & Waste Management Division
4300 Cherry Creek Drive South
Denver , CO   80246-1530
(303)692-3300
Fax: (303)759-5355
X-Ray facilities must be registered with the Division prior to operation.

Link:  http://www.cdphe.state.co.us/hm/rad/xray/xray.asp

Mammography inspections are performed annually based on federal Food ad Drug Administration (FDA) requirements, known as the Mammography Quality Standards Act (MQSA).

Link:  http://www.fda.gov/cdrh/mammography/guidance-docs.html

All x-ray machines must be registered with the division.
All new x-ray machines must be inspected by a qualified x-ray inspector within 90 days of installation.
All x-ray machines must be inspected on the following schedule by a qualified inspector: Annually: hospitals, chiropractors, MDs and DOs. Every 2 years: industrial users (airports) Every 3 years: Dentists, Podiatrists, and Veterinarians. Qualified Inspector certification obtained from the division. $50/yr. fee. The division maintains lists of qualified inspectors for distribution.
All x-ray service companies must also be registered with the CDPHE with an annual fee of $50.
State
Colorado Department of Public Health & Environment
Health Facilities Division
4300 Cherry Creek Drive South
Denver , CO   80246-1530
(303)692-2800
A portable diagnostic X-ray supplier must be registered with the Health Facilities Division. Tests must be under the supervision of a physician.

Link:  http://www.cdphe.state.co.us/hf/static/xray.htm

State
Colorado Division of Registrations
State Board of Medical Examiners
1560 Broadway #1300
Denver , CO   80202
(303)894-7690
Fax: (303)894-7692
X-Ray Technicians are not licensed by the State. However, persons not possessing a medical license who operate machine sources of ionizing radiation or who administer such radiation to patients for diagnostic medical use, outside of a hospital setting, must demonstrate competency via satisfactory passage of the limited scope examination administered by The American Registry of Radiologic Technologists (“ARRT”).

Link:  http://www.dora.state.co.us/medical/main-x-ray.htm

Unlicensed personnel administering x-rays in other professions (dental, veterinary, etc.) must meet training, supervision, and reporting requirements of the appropriate examining boards.

NOTE:  See MANUFACTURING regarding applicable environmental regulations.
NOTE:  If appropriate, see MEDICAL EQUIPMENT (manufacturing or importing).
NOTE:  See RADIOGRAPHER for non-medical Radiography.
Colorado Office of Economic Development and International Trade (303) 892-3840 oedit.info@state.co.us
Colorado Office of Economic Development and International Trade (303) 892-3840 oedit.info@state.co.us
Colorado Office of Economic Development and International Trade (303) 892-3840 oedit.info@state.co.us
Colorado Office of Economic Development and International Trade (303) 892-3840 oedit.info@state.co.us