FDA.reportPublic FDA data

Delta

Primary DI
04718018530209
Brand
Delta
Company
DELTA ELECTRONICS, INC. CHUNGLI 5 PLANT
Model
DMG-80KAX B
Catalog number
DMP-100RF
Published
2024-06-03
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
14718018530206PackageGS11In Commercial Distribution
04718018530209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471801853020614718018530206
04718018530209047180185302094718018530209

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.

Regulatory Flags#

DUNS number
658698699
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
04718018530124DeltaDMG-32KAX ADMP-100RF2024-06-03
04718018530131DeltaDMG-32KAX BDMP-100RF2024-06-03
04718018530148DeltaDMG-40KAX ADMP-100RF2024-06-03
04718018530155DeltaDMG-40KAX BDMP-100RF2024-06-03
04718018530162DeltaDMG-50KAX BDMP-100RF2024-06-03
04718018530179DeltaDMG-56KAX BDMP-100RF2024-06-03
04718018530186DeltaDMG-65KAX BDMP-100RF2024-06-03
04718018530193DeltaDMG-71KAX BDMP-100RF2024-06-03
04718018530216DeltaDMG-82KAX BDMP-100RF2024-06-03
14718018530121DeltaDMG-32KAX ADMP-100RF2024-06-03
14718018530138DeltaDMG-32KAX BDMP-100RF2024-06-03
14718018530145DeltaDMG-40KAX ADMP-100RF2024-06-03
14718018530152DeltaDMG-40KAX BDMP-100RF2024-06-03
14718018530169DeltaDMG-50KAX BDMP-100RF2024-06-03
14718018530176DeltaDMG-56KAX BDMP-100RF2024-06-03
14718018530183DeltaDMG-65KAX BDMP-100RF2024-06-03
14718018530190DeltaDMG-71KAX BDMP-100RF2024-06-03
14718018530206DeltaDMG-80KAX BDMP-100RF2024-06-03
14718018530213DeltaDMG-82KAX BDMP-100RF2024-06-03
04718018530100DeltaMDS-00010DMP-100R, DMP-100RF2024-01-22

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