3D TPR

Primary DI
05060608880300
Brand
3D TPR
Company
SUN NUCLEAR CORP.
Model
1230680Z
Catalog number
1230000-4Z
Device description
Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio
Published
2019-04-23
Public version status
Update
Distribution status
Not 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
B01612300004Z0PreviousHIBCC0
05060608880300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880300050606088803005060608880300

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 Atmospheric Pressure18.7 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Do not keep 3D TPR in water for longer than 24 hours.
Special Storage Condition, Specify00Do not store the instrument in the treatment room.
Special Storage Condition, Specify00Ensure that all 3D TPR parts, including cable and connector, are clean and dry before placing in storage case. Dry with a soft cloth. Never use abrasive cleaners.
Special Storage Condition, Specify00For transport and storage within the facility, 3D TPR can remain attached to the Water Tank, but it is recommended to store 3D TPR in its case when not in use.
Special Storage Condition, Specify00If connector is accidentally immersed in water, allow to dry completely before connecting to 3D SCANNER.
Special Storage Condition, Specify00Never expose the 3D TPR electronic circuits to the direct radiation beam.
Special Storage Condition, Specify00Never leave the instrument on the couch during delivery system warm up.
Special Storage Condition, Specify00Store 3D TPR in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Storage Environment Atmospheric Pressure57.2 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

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

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