FDA.reportPublic FDA data

ISORAD Detector, 6-12MV (+) 3m

Primary DI
05060608880553
Brand
ISORAD Detector, 6-12MV (+) 3m
Company
SUN NUCLEAR CORP.
Model
11630003Z
Catalog number
11630003Z
Device description
Radiation therapy QA device
Published
2019-05-21
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
IWBSystem, Radiation Therapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWBSystem, Radiation Therapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912250000ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODESTheta Systems, Inc.1991-11-05IWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01611630003Z0PreviousHIBCC0
05060608880553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880553050606088805535060608880553

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00After cleaning, allow the detector, cable and connector to dry thoroughly, and then place in the storage case along with any accessories.
Special Storage Condition, Specify00Store in an indoor, protected environment where the detector will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify00When shipping a detector, always pack in a shipping container designed for fragile objects.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
122240021
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974783050023SMD-XGD/AR GalaxyOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-30
06974783050009SMD Galaxy RTxOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-26
07340201502136Leksell GammaPlanElekta Solutions ABIWB2024-02-14
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