FDA.reportPublic FDA data

3D Reservoir

Primary DI
B01612300002Z0
Brand
3D Reservoir
Company
SUN NUCLEAR CORP.
Model
12300002Z
Catalog number
12300002Z
Device description
Accessory to the 1230 3D SCANNER.
Published
2017-01-14
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
K101992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1019920003D SCANNER, MODEL 1230Sun Nuclear Corp.2010-10-01IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01612300002Z0PrimaryHIBCC0

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
Special Storage Condition, Specify00Do not store equipment inside the 3D Reservoir.
Special Storage Condition, Specify00Do not store equipment on top of the 3D Reservoir.
Special Storage Condition, Specify00Never expose the electronics portion of the 3D Reservoir to the beam, including where it could be exposed during rotation.
Special Storage Condition, Specify00Never store the 3D Reservoir where it can accidentally be irradiated.
Special Storage Condition, Specify00Store the instrument in an indoor, protected environment where it 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 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22