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

Reportable 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.

In addition to Performance Standard compliance, Accidental Radiation Occurence reporting, etc., U.S. FDA typically requires that additional Product Reports to be submitted for the Radiation-Emitting Electronic Device examples listed below.

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

Angiographic X-Ray System Automotive Accessory
Bone Densitometer Cabinet X-Ray (Industrial)
Cabinet X-Ray (Security) Cabinet X-Ray (Vehicle/Cargo)
Cathode Ray Tubes CD/CD-Rom Player
CD-R/CD-RW Recorder Cell Counter (Automated)
Cell Sorter Cephalometer
Cephalometric Devices Cranial Orthosis
Dental X-Ray Film Holder Diagnostic X-Ray Tube Mount
Digital Breast Tomosynthesis Digital Display Monitor
DVD, Bluray or HD Recorder Ear Oximeter
Extraoral Source X-Ray System Extraoral Source X-Ray System
Gynecologic Surgical Laser Image Digitizer
Infrared Lamp Intraoral Source X-Ray System
Laser (Alignment) Laser (Coronary Angioplasty)
Laser (Dental) Laser (Gastro-Urology)
Laser (Geodimeter Ranging) Laser (Guide-Star)
Laser (Ion) Laser (Metal Deposition)
Laser (Research) Laser (Science Education)
Laser (Surveying) Laser (Target Designator)
Laser (Toy/Novelty) Laser (Traffic Signal)
Laser Cutter Laser Fax Machine
Laser Light Show (High-Power) Laser Marker/Engraver
Laser Micrometer Laser Mouse/Trackball
Laser Pointer Laser Printer
Laser System (Excimer) Laser Therapy Product
Laser Video Projector Laser Vision
Laser Welder Lead-Lined Position Indicator
Mammographic X-Ray System Medical Image Digitizer
Medical Image Storage Device Mercury Vapor Lamp
Metal Halide Lamp Microwave Diathermy
Microwave Oven (Commercial) Microwave Oven (Consumer)
Mobile X-Ray System Neonatal Phototherapy Unit
Nonfetal Ultrasonic Monitor Ophthalmic Laser
Ophthalmic Photocoagulator Ophthalmoscope
Oscilloscope (Exempted) Oximeter
Personnel Protective Shield Phacofragmentation System
Pneumoencephalographic Chair Powered Muscle Stimulator
Print Industry Plate Maker Projector
Radiographic Grid Radiographic Head Holder
Radiologic Patient Cradle Radiologic Table
Remote Controller Reprographics
RF/Microwave (Hyperthermia) Spectroscopy Instrument
Stationary X-Ray System Stimulator (Ultrasound)
Sunlamp System (Tabletop) Suntan Bed
Suntan Lamp Surgical Camera & Accessories
Tomographic X-Ray System Tunnel/Conveyor
TV View Finder (Exempted) Ultrasonic Diathermy
Ultraviolet Lamp For Tanning UPC Reader (Bar Code Reader)
Urine Particle Counter Vending Machine
Veterinary Laser Visual Field Laser Instrument
X-Ray Controls (Combination) X-Ray Controls (Fluoroscopic)
X-Ray Controls (Radiographic) X-Ray Image Receptor




 
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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