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

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