• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Radiation-Emitting Products

  • Print
  • Share
  • E-mail

Download Radiation-Emitting Electronic Product Codes Files

Files

These files are replaced monthly, usually on the 5th of each month.

File Description

FOI_Rad_Emitting_Pcode.txt

  Data Elements
1 Product Code (3 characters) unique product identifier
2 Product Name (120 characters)
3 Radiation Type Code (2 characters)
4 Performance Standard (4000 characters)
5 Medical specialty Code (2 characters)
6 Radiological_Category_code (2 characters)
7 Device Definition (2000 characters)

Radiation_Types_List.txt

  Data Elements
1 Radiation Type Code (2 characters)
2 Radiation Type (60 characters)

Radialogical_Categories_List.txt

  Data Elements
1 Radiological Category Code (2 characters)
2 Radiological Category (120 characters)

Product Code

System generated three (3) character unique identifier of device.

 Product Name

The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas. Therefore, the first word in the device name is usually the best search parameter. For example, to find a specific pump, search on the word "pump" to retrieve all products with the word "pump" in their name.

Performance Standard

Performance standard specifies the radiation safety performance standard(s) applicable under FDA’s electronic product radiation control requirements. Any electronic product or medical device emitting radiation may be subject to a performance standard.

The CDRH database links to the appropriate performance standard contained in Title 21, Code of Federal Regulations. If the database references multiple performance standards, all may be applicable. If the database does not reference a performance standard, no standard is applicable.

Radiation Types

Radiation type describes the electronic product radiation emitted from the device, and may include ionizing, optical, microwave or EMF, and acoustic.

 Radiation Type Code Radiation Type
94 Ionizing
95 Optical
96 Microwave EMF
97 Acoustic
99 N/A

Radiological Category

Radiological Category describes the radiation-emitting electronic products.

Radiological Category Radiological Category Code
Analytical X-Ray Systems, Non-Medical 14
Cabinet X-Ray Systems, Medical 66
Cabinet X-Ray Systems, Non-Medical 17
Cargo Non-Intrusive Security Systems 57
Cathode Ray Tube (without Electronics Chassis) 05
Cold-Cathode Gas Discharge Tubes 08
Data Measurement, Transmit, Control Laser Products 48
Dental Diagnostic X-Ray Equipment 18
Diagnostic Nuclear Medicine Devices 26
Diagnostic Ultrasound Device 23
Diagnostic X-Ray Equipment (Non-Certified) 12
General Optical Products, Medical 62
General Optical Products, Non-Medical 63
High Voltage Vacuum Switches 06
High Voltage Vacuum Tubes 04
Household ELF Products 36
In Vitro and Other Medical Laser Products 50
Industrial Dielectric Heaters 27
Industrial Particle Beam Systems 38
Industrial X-Ray Systems (Excluding Cabinet 13
Industrial X-Ray Systems (Excluding Cabinet) 29
Laser Products (Pre-Standard) 10
Material Processing Laser Products 47
Medical Accelerators 11
Medical Diagnostic X-Ray Equipment 16
Medical Laser Products 34
Mercury Vapor Lamps 28
Microwave Communication, Data Transmit, and Measurement Products 54
Microwave Diathermy Machines 03
Microwave Heating and Drying Products 02
Microwave Hyperthermia Therapy Devices 33
Microwave Identification, Safety, Security, and Surveillance Products 53
Microwave Medical Products 52
Microwave Ovens (Food Prep) 01
Non-Medical Accelerators 65
Nuclear Magnetic Resonance Devices 32
Other Demonstration Laser Products 40
Other Laser Products 22
Other Microwave Products 55
Personnel Security Systems 56
Positioning Medical Laser Products 51
Radioisotope Therapy Devices 25
Research, Scientific, Laboratory Laser Products 44
Safety, Security, Surveillance Laser Products 46
Sonic Medical Products 64
Sonic Non-Medical Products 35
Sunlamp Products (Certified) 30
Sunlamp Products (Pre-Standard) 19
Surveying, Leveling, Alignment Laser Products 45
TV Receivers & Products Containing Same 07
Therapeutic Ultrasonic Devices (Certified) 24
Therapeutic X-Ray Systems 15
Toy, Novelty, Play Laser Products 41
Ultrasonic Medical Devices (Miscellaneous) 31
Ultrasound Non-Medical Devices 09
Ultraviolet Commercial/Consumer Products 61
Ultraviolet Hygiene Products 60
Ultraviolet Medical Products 58
Ultraviolet Surveillance & Detection Products 59
Utility/Peripheral Laser Products 49
Veterinary Diagnostic Ultrasonic Products 42
Veterinary Therapy Ultrasonic Products 43
Veterinary X-Ray Systems 37
X-Ray Bone Densitometers 39
X-Ray Film and Film Processing Materials 21

Medical Specialty

Two letters indicate the medical specialty panel responsible for reviewing the product.

Medical Specialty (Advisory Committee) Regulation No. Medical Specialty Code
Anesthesiology Part 868 AN
Cardiovascular Part 870 CV
Clinical Chemistry Part 862 CH
Dental Part 872 DE
Ear, Nose, & Throat Part 874 EN
Gastroenterology & Urology Part 876 GU
General Hospital Part 880 HO
Hematology Part 864 HE
Immunology Part 866 IM
Microbiology Part 866 MI
Neurology Part 882 NE
Obstetrics/Gynecology Part 884 OB
Ophthalmic Part 886 OP
Orthopedic Part 888 OR
Pathology Part 864 PA
Physical Medicine Part 890 PM
Radiology Part 892 RA
General & Plastic Surgery Part 878 SU
Clinical Toxicology Part 862 TX

  Regulation Number

The CDRH database links medical devices to the appropriate regulation that contains a product definition and is published in Title 21, Code of Federal Regulations. If the database does not reference a regulation number, the device has not yet been classified and the device class listed (1, 2, or 3) is proposed, not final.

Device Definition

Definition of device, based upon nomenclature experts which incorporates definition components of device.