FDA.reportPublic FDA data

Varex Imaging

Primary DI
08718755000962
Brand
Varex Imaging
Company
Varex Imaging Nederland B.V.
Model
14181-10
Device description
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator.This device is one out of the AmpMC-series.
Published
2019-07-24
Public version status
Update
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
08718755000962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718755000962087187550009628718755000962

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel radiation survey meterA survey meter or area monitor with a spectrometer to separate pulses received from a detector according to pulse size. Pulse size is proportional to energy of the detected radiation. It typically consists of a detector (usually a scintillation or semiconductor detector), a linear amplifier, an analogue-to-digital converter (ADC), a computer memory for storing information from the ADC, a scalar or count rate meter. The memory permits automated data processing, e.g., background subtraction and spectrum striping, which permits the analysis of complex spectra.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413223942
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
08718755004106Varex ImagingSolidStateMC 5022025-09-30
08718755004113Varex ImagingSolidStateMC 5062025-09-30
08718755004144Varex ImagingSolidStateMC 5212025-09-30
08718755004168Varex ImagingSolidStateMC 6052025-09-30
08718755004182Varex ImagingSolidStateMC 6102025-09-30
08718755004199Varex ImagingSolidStateMC 6132025-09-30
08718755004205Varex ImagingSolidStateMC 6142025-09-30
08718755004212Varex ImagingSolidStateMC 6162025-09-30
08718755004243Varex ImagingSolidStateMC 6212025-09-30
08718755004120Varex ImagingSolidStateMC 5082025-09-30
08718755004137Varex ImagingSolidStateMC 5102025-09-30
08718755004151Varex ImagingSolidStateMC 6012025-09-30
08718755004175Varex ImagingSolidStateMC 6092025-09-30
08718755004229Varex ImagingSolidStateMC 6172025-09-30
08718755004236Varex ImagingSolidStateMC 6192025-09-30
08718755004250Varex ImagingSolidStateMC 6252025-09-30
08718755004090Varex ImagingSolidStateMC 5012025-09-17
08718755004052Varex ImagingOPTICA10-00-001-005-OEM2022-09-23
08718755004069Varex ImagingOPTICA10-00-004-005-OEM2022-09-23
08718755003208Varex ImagingOPTICA10-01-065-001-OEM2022-04-04

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