Others titles
- FDA Radiation-Emitting Electronic Product Codes
- Radiation-Emitting Product Codes
- Radiation Emitting Elements
- Radiation Emitting Elements Data
Keywords
- Radiation
- Radiation-Emitting
- Radiation emitting devices
- Radiation safety performance standard
- Radiation Therapy
- Radiation-Emitting Data
- Radiation Emitting Devices
- Radiation Safety Performance Standard
Radiation-Emitting Electronic Product Codes
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.
Get The Data
- Research
Non-Commercial, Share-Alike, Attribution Free Forever - CommercialCommercial Use, Remix & Adapt, White Label
Log in to download
Non-Commercial, 
Share-Alike, 
Attribution 
Commercial Use, 
Remix & Adapt, 
White Label
Description
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.
About this Dataset
Data Info
| Date Created | 2015-03-19 |
|---|---|
| Last Modified | 2020-10-18 |
| Version | 2020-10-18 |
| 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 |
Data Fields
| Name | Description | Type | Constraints |
|---|---|---|---|
| Product_Code | System generated three (3) character unique identifier of device. | string | unique : 1required : 1 |
| Product_Name | The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas. | string | required : 1 |
| Radiation_Type_Code | 99 N/A | integer | level : Nominalrequired : 1 |
| 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. | string | - |
| Medical_Specialty_Code | Two letters indicate the medical specialty panel responsible for reviewing the product. | string | - |
| Device_Definition | Definition of device, based upon nomenclature experts which incorporates definition components of device. | string | - |
| Radiological_Category_Code | Radiological Category describes the radiation-emitting electronic products | integer | level : Nominal |
Data Preview
| Product Code | Product Name | Radiation Type Code | Performance Standard | Medical Specialty Code | Device Definition | Radiological Category Code |
| BWA | Unit, Electrosurgical And Coagulation, With Accessories | 96 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | SU | 52 | |
| CBA | Monitor, Air Embolism, Ultrasonic | 97 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | AN | 23 | |
| DJS | U.V. Light, Tlc | 95 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | CH | 58 | |
| DPW | Flowmeter, Blood, Cardiovascular | 97 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | CV | 23 | |
| DPZ | Oximeter, Ear | 95 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | CV | 62 | |
| DQA | Oximeter | 95 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | CV | 62 | |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 96 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | CV | 52 | |
| DWG | Electrosurgical Device | 96 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | SU | 52 | |
| DXK | Echocardiograph | 97 | No standard applicable. General Radiological Health requirements apply. [1000-1005]; | CV | 23 | |
| EAG | Cephalometer | 94 | Diagnostic x-ray systems and their major components. [1020.30]; Radiographic equipment. [1020.31]; | DE | 18 |
16192 Coastal Highway
