FDA.reportPublic FDA data

MOBILE DR

Primary DI
00885310000342
Brand
MOBILE DR
Company
Communications & Power Industries Canada Inc
Model
VZW2559RH1
Device description
Generator, High-Voltage, X-Ray, Diagnostic, MOBILE DR, RAD, 32kW, 240V
Published
2020-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZOGenerator, High-Voltage, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZOGenerator, High-Voltage, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885310000342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885310000342008853100003428853100003420885310000342

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, mobileAn x-ray generator with special size, weight, and power requirements that makes it suitable for use in a mobile x-ray system, e.g., a system designed to be pushed or driven to various locations within a facility. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer, inverter, and capacitor discharge generator designs. It typically comprises a control assembly (console) and high voltage transformer assembly or is of a mono-tank generator design. This generator is an integral component of a mobile diagnostic x-ray system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height13.6Inch
Length14.7Inch
Width14.6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure525 Millimeter of Mercury825 Millimeter of Mercury
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202887311
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885310000038CMP 200 DRVZW2556RB2NA2020-07-24
00885310000045CMP200 DRVZW2556RB32020-07-24
00885310000052CMP 200 DRVZW2556RB42020-07-24
00885310000069CMP 200 DRVZW2556RC22020-07-24
00885310000076CMP 200 DRVZW2556RC32020-07-24
00885310000083CMP 200 DRVZW2556RD22020-07-24
00885310000090CMP 200 DRVZW2556RD32020-07-24
00885310000106CMP 200 DRVZW2556RE22020-07-24
00885310000113CMP 200 DRVZW2556RE32020-07-24
00885310000120CMP 200 DRVZW2556RE42020-07-24
00885310000137CMP 200 DRVZW2556RE52020-07-24
00885310000144CMP 200 DRVZW2556RH22020-07-24
00885310000151CMP 200 DRVZW2556RH32020-07-24
00885310000168CMP 200 DRVZW2556RH42020-07-24
00885310000175CMP 200 DRVZW2556RH52020-07-24
00885310000229Indico IQVZW2558FB22020-07-24
00885310000236Indico IQVZW2558FB32020-07-24
00885310000243Indico IQVZW2558FB82020-07-24
00885310000250Indico IQVZW2558FC22020-07-24
00885310000267Indico IQVZW2558FC32020-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00055846500108Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
00055846500115Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
00055846500122Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
08718755004106Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004113Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004144Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004168Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004182Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004199Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004205Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004212Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004243Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004120Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004137Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004151Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004175Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004229Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004236Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004250Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004090Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-17
06973858210492Medical X-ray High Frequency High Voltage GeneratorSuzhou Powersite Electric Co., LTDIZO2025-05-29
08800011110437DRGEMDRGEM CorporationIZO2025-05-28
08800011110444DRGEMDRGEM CorporationIZO2025-05-28
08800011110451DRGEMDRGEM CorporationIZO2025-05-28
08800011110468DRGEMDRGEM CorporationIZO2025-05-28
08800011110475DRGEMDRGEM CorporationIZO2025-05-28
08800011110482DRGEMDRGEM CorporationIZO2025-05-28
08800011110499DRGEMDRGEM CorporationIZO2025-05-28
08800011110505DRGEMDRGEM CorporationIZO2025-05-28
08800011110512DRGEMDRGEM CorporationIZO2025-05-28