X-Ray Assembler Components

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X-Ray Assembler Components dataset contains the releasable information submitted on form Food and Drug Administration (FDA) 2579 Block 4(h) – under Component Information.

Complexity

X-Ray Assembler Components dataset contains information about Components for each X-Ray Assembler Equipment.

Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly (Form FDA 2579) to FDA within 15 days following the completion of the assembly. The report constitutes the assembler’s certification that the components installed are of the type called for by regulations, and that the components were assembled, installed, adjusted, and tested in accordance with the manufacturer’s instructions and meet all applicable performance requirements.

Date Created

2015-02

Last Modified

2018-07-30

Version

2018-07-30

Update Frequency

Weekly

Temporal Coverage

1987 to 2018

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

X-Ray Assembler, X-Ray Components

Other Titles

X-Ray Assembler Components, X-Ray Components, Medical Device, FDA X-Ray, X-Ray Devices

Name Description Type Constraints
IDID of X-Ray Assembler Equipmentstringunique : 1 required : 1
XRay_ControlXRAY CONTROL deviceintegerrequired : 1 level : Ratio
High_Voltage_GeneratorHIGH VOLTAGE GENERATOR deviceintegerrequired : 1 level : Ratio
Vertical_Cassette_HolderVERTICAL CASSETTE HOLDER deviceintegerrequired : 1 level : Ratio
Tube_Housing_AssemblyTUBE HOUSING ASSEMBLY deviceintegerrequired : 1 level : Ratio
Dental_Tube_HeadDENTAL TUBE HEAD deviceintegerrequired : 1 level : Ratio
CradleCRADLE deviceintegerrequired : 1 level : Ratio
Film_ChangerFILM CHANGER deviceintegerrequired : 1 level : Ratio
Image_IntensifierIMAGE INTENSIFIER deviceintegerrequired : 1 level : Ratio
Spot_Film_DeviceSPOT FILM DEVICEintegerrequired : 1 level : Ratio
Fluoroscopic_Imaging_AssemblyFLUOROSCOPIC IMAGING ASSEMBLY deviceintegerrequired : 1 level : Ratio
Cephalometric_DeviceCEPHALOMETRIC DEVICEintegerrequired : 1 level : Ratio
Image_ReceptorIMAGE RECEPTOR deviceintegerrequired : 1 level : Ratio
Image_Receptor_Support_DeviceIMAGE RECEPTO RSUPPORT DEVICEintegerrequired : 1 level : Ratio
Fluoroscopic_Air_Kerma_DeviceFLUOROSCOPIC AIR KERMA DEVICEintegerlevel : Ratio
OtherOTHER EQUIPMENTintegerlevel : Ratio
Other_TextOther textstring-
IDXRay_ControlHigh_Voltage_GeneratorVertical_Cassette_HolderTube_Housing_AssemblyDental_Tube_HeadCradleFilm_ChangerImage_IntensifierSpot_Film_DeviceFluoroscopic_Imaging_AssemblyCephalometric_DeviceImage_ReceptorImage_Receptor_Support_DeviceFluoroscopic_Air_Kerma_DeviceOtherOther_Text
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