Radiation-Emitting Electronic Product Codes

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The Radiation-Emitting Electronic Product Codes Database contains names of radiation-emitting electronic products and devices and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission.

Complexity

Radiation-emitting products run the gamut from diagnosing serious medical conditions through such things as X-rays and mammograms to helping ensure the safety of airports and office buildings with security X-rays to making modern life a little easier with microwave ovens and cell phones.

The Radiation-Emitting Electronic Product Codes database contains product names and their associated product codes. Additionally, the radiation type, definition, and applicable performance standards (21 CFR Parts 1020-1050) are provided.

The Performance Standards listed in the dataset are the applicable Federal performance standards to which the products must comply, versus any standards listed under the recognized consensus or voluntary standards heading for medical devices.
If the database references multiple performance standards, all may be applicable. If the database does not reference a performance standard, no standard is applicable.

Date Created

2015-03-19

Last Modified

2018-05-14

Version

2018-05-14

Update Frequency

Monthly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Radiation, Radiation-Emitting, Radiation emitting devices, Radiation safety performance standard, Radiation Therapy, Radiation-Emitting Data, Radiation Emitting Devices, Radiation Safety Performance Standard

Other Titles

FDA Radiation-Emitting Electronic Product Codes, Radiation-Emitting Product Codes, Radiation Emitting Elements, Radiation Emitting Elements Data

NameDescriptionTypeConstraints
Product_CodeSystem generated three (3) character unique identifier of device.stringunique : 1 required : 1
Product_NameThe Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas.stringrequired : 1
Radiation_Type_Code99 N/Aintegerrequired : 1 level : Nominal
Performance_StandardPerformance 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.string-
Medical_Specialty_CodeTwo letters indicate the medical specialty panel responsible for reviewing the product.string-
Device_DefinitionDefinition of device, based upon nomenclature experts which incorporates definition components of device.string-
Radiological_Category_CodeRadiological Category describes the radiation-emitting electronic productsintegerlevel : Nominal
Product_CodeProduct_NameRadiation_Type_CodePerformance_StandardMedical_Specialty_CodeDevice_DefinitionRadiological_Category_Code
KEXSorter, Cell95Laser products. [1040.10];50
LKMCounter, Urine Particle95Laser products. [1040.10];HE50
GKZCounter, Differential Cell95Laser products. [1040.10];HE50
MSQTest, Urea (Breath Or Blood)95Laser products. [1040.10];MI50
MWPCabinet, X-Ray System94Cabinet x-ray systems. [1020.40];RA66
MYYSeparator, Semi-Automated, Blood Component95Laser products. [1040.10];50
MZKSystem, Separation, Hematopoietic Stem Cell95Laser products. [1040.10];50
GKLCounter, Cell, Automated (Particle Counter)95Laser products. [1040.10];HE50
PGFRed Cell Thawer, Microwave96HEFor thawing red cells prior to transfusion.52
GKTSeparator, Automated, Blood Cell, Diagnostic95Laser products. [1040.10];HE50