FDA.reportPublic FDA data

ArcCHECK

Primary DI
B01612200000Z0
Brand
ArcCHECK
Company
SUN NUCLEAR CORP.
Model
12200000Z
Catalog number
12200000Z
Device description
Radiation therapy QA device.
Published
2017-01-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
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
K131466000
K142617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131466000MAPCHECK2, ARCCHECKSun Nuclear Corporation2013-08-20IYE
K142617000ArcCHECKSun Nuclear Corporation2015-11-20IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060608880027PrimaryGS10
B01612200000Z0PrimaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880027050606088800275060608880027

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system quality assurance deviceAn instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify00Store the ArcCHECK in an indoor, climate-controlled environment.
Special Storage Condition, Specify00When shipping or transporting the ArcCHECK, ensure the shipping temperature and humidity meet the Handling Specifications.
Special Storage Condition, Specify00When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 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
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
05060608881208SunSILICON P10492025-07-08
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

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00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
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