Download Radiation-Emitting Electronic Product Codes Files

Files

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

• FOI_Rad_Emitting_Pcode.txt
• Radiation_Types_List.txt
• Radiological_Categories_list.txt

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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)

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Radiation_Types_List.txt

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

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Radialogical_Categories_List.txt

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

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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

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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

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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.