FDA.report

Varex Imaging

Primary DI
08718755000993
Brand
Varex Imaging
Company
Varex Imaging Nederland B.V.
Model
12838-10
Device description
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Published
2019-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IZOGenerator, High-Voltage, X-Ray, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
IZOGenerator, High-Voltage, X-Ray, DiagnosticRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08718755000993PrimaryGS10

GMDN Terms

TermDefinition
Solid-state-semiconductor radiation measuring probeA device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity and its energy discrimination properties allow it to be incorporated in radiation detection, measurement instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray, high-energy beta particles or neutrons) that can be detected.

Sterilization Methods

Method

Regulatory Flags

DUNS number
413223942
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
08718755003215Varex ImagingOPTICA10-01-000-001-OEM2022-04-04
08718755003222Varex ImagingOPTICA10-01-001-001-OEM2022-04-04
08718755003239Varex ImagingOPTICA10-01-002-001-OEM2022-04-04
08718755003246Varex ImagingOPTICA10-01-003-001-OEM2022-04-04
08718755003253Varex ImagingOPTICA10-01-004-001-OEM2022-04-04
08718755003260Varex ImagingOPTICA10-01-005-001-OEM2022-04-04
08718755003277Varex ImagingOPTICA10-01-006-001-OEM2022-04-04
08718755003284Varex ImagingOPTICA10-01-007-001-OEM2022-04-04
08718755003291Varex ImagingOPTICA10-01-008-001-OEM2022-04-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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08718755003550Varex ImagingVarex Imaging CorporationIZO2025-02-25
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