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

2020-08-10

Version

2020-08-10

Update Frequency

Quarterly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

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

Source License URL

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/Aintegerlevel : Nominal required : 1
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
BWAUnit, Electrosurgical And Coagulation, With Accessories96No standard applicable. General Radiological Health requirements apply. [1000-1005];SU52
CBAMonitor, Air Embolism, Ultrasonic97No standard applicable. General Radiological Health requirements apply. [1000-1005];AN23
DJSU.V. Light, Tlc95No standard applicable. General Radiological Health requirements apply. [1000-1005];CH58
DPWFlowmeter, Blood, Cardiovascular97No standard applicable. General Radiological Health requirements apply. [1000-1005];CV23
DPZOximeter, Ear95No standard applicable. General Radiological Health requirements apply. [1000-1005];CV62
DQAOximeter95No standard applicable. General Radiological Health requirements apply. [1000-1005];CV62
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency96No standard applicable. General Radiological Health requirements apply. [1000-1005];CV52
DWGElectrosurgical Device96No standard applicable. General Radiological Health requirements apply. [1000-1005];SU52
DXKEchocardiograph97No standard applicable. General Radiological Health requirements apply. [1000-1005];CV23
EAGCephalometer94Diagnostic x-ray systems and their major components. [1020.30]; Radiographic equipment. [1020.31];DE18