FDA.reportPublic FDA data

EDGE Detector (TNC)

Primary DI
05060608880614
Brand
EDGE Detector (TNC)
Company
SUN NUCLEAR CORP.
Model
11180001Z
Catalog number
11180001Z
Device description
Radiation therapy QA device.
Published
2019-06-12
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
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051921000THE EDGE DETECTOR, MODEL 1118Sun Nuclear Corp.2005-07-27IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01611180001Z0PreviousHIBCC0
05060608880614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880614050606088806145060608880614

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
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Store where the detector will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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05060608881512Precision Cut GafChromic™ Film15822024-11-01
05060608881178Precision Cut EBT3 GafChromic™ Film1582002024-01-02
05060608880089SRS PROFILER1202500Z1202000-0Z2019-09-17
05060608881123SunSCAN 3D12341234900Z2023-06-08
05060608881130SunSCAN 3D12351235900Z2023-06-08
B136159A0Phototimer Consistency Tools159A2021-12-01
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B136115H0Sun Nuclear 115H Half Value Layer Attenuator Set115H2021-08-27
B13614640Sun Nuclear Advanced iqModule14642021-08-27
B13614670Sun Nuclear Advanced Electron Density Phantom14672021-08-27
B13614720Sun Nuclear Multi-Energy CT Phantom14722021-08-27
B136159ABR0Sun Nuclear Phototimer Consistency Tools159ABR2021-08-27

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