FDA.reportPublic FDA data

S Spellman High Voltage Electronics Corporation

Primary DI
06975490630096
Brand
S Spellman High Voltage Electronics Corporation
Company
Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd
Model
ZR75PN40
Device description
ZR75PN40, Mini console without handswitch
Published
2022-12-06
Public version status
New
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
06975490630096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975490630096069754906300966975490630096

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, stationaryA generator which is an integral component of a stationary diagnostic x-ray system, e.g., a system intended to be operated at a fixed location within a facility or mobile imaging van. It is used to regulate incoming voltage and current 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 typically comprises a control assembly (console) and high voltage transformer assembly, or it is of a mono-tank generator design and includes transformer, constant potential, inverter and capacitor discharge generator designs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529124841
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975490630379S Spellman High Voltage Electronics Corporation409085-0022022-12-08
06975490630386S Spellman High Voltage Electronics Corporation409085-0072022-12-08
06975490630010S Spellman High Voltage Electronics CorporationZR75PN652022-12-06
06975490630027S Spellman High Voltage Electronics CorporationZR75PN322022-12-06
06975490630034S Spellman High Voltage Electronics CorporationZR75PN322022-12-06
06975490630041S Spellman High Voltage Electronics CorporationZR75PN322022-12-06
06975490630058S Spellman High Voltage Electronics CorporationZR75PN322022-12-06
06975490630065S Spellman High Voltage Electronics CorporationZR75PN322022-12-06
06975490630072S Spellman High Voltage Electronics CorporationZR75PN402022-12-06
06975490630089S Spellman High Voltage Electronics CorporationZR75PN402022-12-06
06975490630102S Spellman High Voltage Electronics CorporationZR75PN402022-12-06
06975490630119S Spellman High Voltage Electronics CorporationZR75PN402022-12-06
06975490630126S Spellman High Voltage Electronics CorporationZR75PN502022-12-06
06975490630133S Spellman High Voltage Electronics CorporationZR75PN502022-12-06
06975490630140S Spellman High Voltage Electronics CorporationZR75PN502022-12-06
06975490630157S Spellman High Voltage Electronics CorporationZR75PN502022-12-06
06975490630164S Spellman High Voltage Electronics CorporationZR75PN502022-12-06
06975490630171S Spellman High Voltage Electronics CorporationZR75PN652022-12-06
06975490630188S Spellman High Voltage Electronics CorporationZR75PN652022-12-06
06975490630195S Spellman High Voltage Electronics CorporationZR75PN652022-12-06

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
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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