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HomeRadiation-Emitting Electronic Device Regulations › Radiation-Emitting Electronic Device Examples

Radiation-Emitting Electronic Device Examples

Any product that contains an electronic circuit and generates any kind of radiation is considered a Radiation-Emitting Electronic Device by the U.S. FDA and must demonstrate compliance to U.S. FDA regulatory requirements.

Examples listed below are typically considered Radiation-Emitting Electronic Devices by U.S. FDA.

NOTE: The following is not a comprehensive list of Radiation-Emitting Electronic Devices. If you have questions about your specific device, please contact us.

Accelerator (Industrial) Accelerator (Security)
AC-Powered Photostimulator Air Traffic Control
Anti-Theft Detector (Non-EAS) Betatron (Non-Medical)
Blood Irradiator Bone Sonometer
Bottle Fill Checker Bronchial Thermoplasty System
CB Amateur Radio Clothes Dryer
Cordless Telephone Cyclotron (Non-Medical)
Dental Operating Light Dental Sonography Device
Echocardiograph Echoencephalograph
Electrohydraulic Lithotriptor Electronic Metal Locator
Endoscope & Accessories Fetal Stethoscope
Fiber Optic Dental Light Fixation Device
Focused Ultrasound Hair Dryer
Hearing Aid (Tactile) High Voltage Tubes
High Voltage Vacuum Switches Humidifier
Immersion Hydrobath Impedance Plethysmograph
Infrared Lamp Intrusion Alarm
Ion Beam Implanter IR Light (Motion Detector)
IR Light (Security) IR Remote Controller
Jewelry Cleaner Lamp (Fluorescent)
Lamp (Tungsten Halogen) Laparoscopic Insufflator
Laser Surgical Instrument LED Mouse/Trackball
Light (Veterinary Medicine) Manual Toothbrush
Massager Mechanical Lithotriptor
Medical Waste/Sterilizer Microscopes and Accessories
Microtron (Non-Medical) Microwave Hair Removal System
Microwave LAN Microwave Medical Products
Motion Detector (Occupancy) Motor
Night Vision Scope Nuclear Rectilinear Scanner
Nuclear Whole Body Counter Nuclear Whole Body Scanner
Operating Headlamp Ophthalmic Surgical Marker
Optical Vision Aid Pest Controller
Pest Repeller Phacofragmentation System
Police Radar Positron Camera
Powered Toothbrush Radiofrequency Lesion Probe
Radiographic Film Radiologic Contrast Medium
Radionuclide Generator Radionuclide Infusion System
Radionuclide Microspheres RF Identification
RF-Excited Lighting Scintillation (Gamma) Camera
Security System Shortwave Diathermy
Sound Amplification Product Sterilizers (Non-Medical)
Stun Gun Surgical Camera & Accessories
Surgical Lamp Synchrotron (Non-Medical)
Telephone Ringer Television
Therapeutic Massager Tissue Processing Equipment
Transilluminator Tweezer-Type Epilator
Ultrasonic Lithotriptor Ultrasonic Scaler
Ultrasonic Scalpel Ultrasonic Transducer
Ultrasound (Contrast Media) Ultrasound (Hyperthermia)
Ultrasoundic Cleaner Ultraviolet Medical Products
UV Lamp UV Light (Cosmetic)
UV Light (Crystallography) UV Light (Curing)
UV Light (Hand Sanitizing) UV Light (Water Purification)
UV/IR Light (Research) Walkie-Talkie
Weather Doppler System Welding Equipment
X-Ray (Diffraction) X-Ray (Fluorescence)
X-Ray (Industrial) X-Ray (Spectroscopy)
X-Ray Thickness Gauge




 
U.S. FDA Regulations:

U.S. FDA Radiation-Emitting Electronic Device Reporting:
21 C.F.R. Part 1002 et seq.

U.S. FDA Radiation-Emitting Electronic Device Performance Standards: 21 C.F.R. Part 1010 et seq.



















































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