FDA.reportPublic FDA data

Del Medical, Inc.

Primary DI
00858340006233
Brand
Del Medical, Inc.
Company
Del Medical, Inc.
Model
Anthem 40-600
Device description
The Anthem Generator is a high-frequency x-ray generator designed for general radiographic applications..
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00858340006233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858340006233008583400062338583400062330858340006233

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

Contacts#

Phone, Email table
PhoneEmail
847-288-7013ggeary@delmedical.com

Regulatory Flags#

DUNS number
078671236
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858340006202Del Medical, Inc.DM-SARM2022-04-15
00858340006479Del Medical, Inc.KA Reveal Mobi Pro2026-03-05
00858340006523Del Medical, Inc.CM-OTC18T2026-03-05
00858340006530Del Medical, Inc.DMX2026-03-05
00858340006547Del Medical, Inc.VT300 (5187)2026-03-05
00858340006486Del Medical, Inc.CM-OTC18M2024-05-09
00858340006400Del Medical, Inc.FM-OTC18T2024-03-18
00858340006417Del Medical, Inc.FM-OTC18M2024-03-18
00858340006424Del Medical, Inc.FM-FMT18T2024-03-18
00858340006431Del Medical, Inc.FM-FMT18M2024-03-18
00858340006448Del Medical, Inc.MT500-F2024-03-18
00858340006455Del Medical, Inc.MT500-EL2024-03-18
00858340006462Del Medical, Inc.MT500-EB2024-03-18
00858340006387Del Medical, Inc.VS502023-05-16
00858340006073Del Medical, Inc.DM-FWFC2022-04-15
00858340006110Del Medical, Inc.OTC18S2022-04-15
00858340006134Del Medical, Inc.EV800T2022-04-15
00858340006141Del Medical, Inc.VT300T2022-04-15
00858340006158Del Medical, Inc.DM-OTC18S2022-04-15
00858340006165Del Medical, Inc.DM-OTC18T2022-04-15

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