FDA.reportPublic FDA data

EDITOR HFe

Primary DI
ESPN0824001040
Brand
EDITOR HFe
Company
Spellman High Voltage Electronics GmbH
Model
401
Catalog number
082400104
Device description
EDITOR HFe401 40kW, ALU UT 400VAC 3Ph.incl. DAP interface
Published
2021-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
ESPN0824001040PrimaryHIBCC0

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
342494647
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
ESPN031480108BAM0EDITOR HFe801383722023-11-27
ESPN091480106INT0EDITOR HFe601091480106-INT2021-06-15
ESPN0824801050EDITOR HFe5010824801052021-02-15
ESPN0814001050EDITOR HFe5010814001052021-02-12
ESPN0814801050EDITOR HFe5010814801052021-02-12
ESPN0824001050EDITOR HFe5010824001052021-02-12
ESPN0812301040EDITOR HFe4010812301042021-02-15
ESPN0824801040EDITOR HFe4010824801042021-02-15
ESPN0824801060EDITOR HFe6010824801062021-02-15
ESPN0824801080EDITOR HFe8010824801082021-02-15
ESPN0814001060EDITOR HFe6010814001062021-02-12
ESPN0814001080EDITOR HFe8010814001082021-02-12
ESPN0814801060EDITOR HFe6010814801062021-02-12
ESPN0814801080EDITOR HFe8010814801082021-02-12
ESPN0824001060EDITOR HFe6010824001062021-02-12
ESPN0824001080EDITOR HFe8010824001082021-02-12
ESPN091480108FL0EDITOR HFe801091480108-FL2020-07-17
ESPN091400106KOD0EDITOR HFe601091400106-KOD2019-09-20
ESPN091400108KOD0EDITOR HFe801091400108-KOD2019-09-20
ESPN091230104AGFA0EDITOR HFe401091230104-AGFA2019-03-04

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