FDA.reportPublic FDA data

SunSILICON P

Primary DI
05060608881208
Brand
SunSILICON P
Company
SUN NUCLEAR CORP.
Model
1049
Device description
The SunSILICON P detector is intended for use as a relative dosimetry detector inmeasurements of ionizing radiation emitted from a treatment delivery device.
Published
2025-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

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
05060608881208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608881208050606088812085060608881208

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 3212596862globalsupport@sunnuclear.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060608881499RapidCHECKRC10002026-05-10
B136RC10000RapidCheckRC10002018-11-28
05060608882045Daily QA™ 4 Pro10982026-02-24
05060608882052Daily QA™ 4 Pro Wireless10982026-02-24
05060608881574Plan AI10572025-11-07
05060608882038Capintec NEMA IEC NM Body PhantomNMP02732025-11-07
05060608881192SunSILICON10482025-07-08
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
B1361150Sun Nuclear 115A Half Value Layer Attenuator Set115A2021-08-27
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
B1362000Sun Nuclear Low Contrast Test Tool2002021-08-27

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Primary DI, Brand, Company table
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