FDA.reportPublic FDA data

3D SCANNER (TNC)

Primary DI
05060608880362
Brand
3D SCANNER (TNC)
Company
SUN NUCLEAR CORP.
Model
1231900Z
Catalog number
1231900Z
Device description
Radiation therapy QA device.
Published
2019-10-09
Public version status
New
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
B01612300000TZ0PreviousHIBCC0
05060608880362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880362050606088803625060608880362

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, Specify00Before storing the 3D SCANNER system, place the protective caps on the electrometer FIELD and REF inputs, ensure that all parts are clean and dry, and then place the dust cover over the Water Tank.
Special Storage Condition, Specify00Do not store any items in the Water Tank that are not used operationally or are not part of the 3D SCANNER system.
Special Storage Condition, Specify00Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments.
Special Storage Condition, Specify00For transport and storage within the facility, the 3D SCANNER water tank can remain attached to the 3D MiniLift or 3D Lift as well as the Automatic Leveling Platform.
Special Storage Condition, Specify00If the 3D SCANNER Water Tank needs transportation independent of the Leveling Platform and 3D MiniLift or 3D Lift, use the four handles on the Lift Ring at the base of the Water Tank for support.
Special Storage Condition, Specify00If the 3D SCANNER, 3D MiniLift, or 3D Lift were shipped in a wood crate, do not re-use the crate for storage or shipping. Accessory shipping cases are available.
Special Storage Condition, Specify00Never store the 3D SCANNER system in an area that is under construction. Excessive dust may reduce the precision of the 3D SCANNER motors and mechanical parts.
Special Storage Condition, Specify00Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room.
Special Storage Condition, Specify00Store the 3D SCANNER system 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.
Special Storage Condition, Specify00The 3D SCANNER, 3D MiniLift or 3D Lift, and Automatic Leveling Platform must be stored in an indoor air-conditioned location.
Special Storage Condition, Specify00To maintain mechanical integrity, do not store water in the Water Tank. Ensure that the system is clean and dry before storing.
Special Storage Condition, Specify00Two person lift required. Use proper lifting and handling techniques to prevent injury or equipment damage. Lift the Water Tank using the four lift handles.
Special Storage Condition, Specify00When measurement is complete, the 3D SCANNER Water Tank can remain attached to the Automatic Leveling Platform and 3D MiniLift or 3D Lift (recommended).
Special Storage Condition, Specify00When shipping/transporting the 3D SCANNER system between facilities, it is recommended to use the accessory shipping cases for the 3D SCANNER Water Tank, Automatic Leveling Platform, and 3D MiniLift.
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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