3D SCANNER (TNC) 12300000TZ

GUDID B01612300000TZ0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device
Primary Device IDB01612300000TZ0
NIH Device Record Key98a3193f-eeb6-45b0-b856-c3d82fb60a4e
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D SCANNER (TNC)
Version Model Number12300000TZ
Catalog Number12300000TZ
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Never 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, SpecifyBetween 0 and 0 *When 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.
Special Storage Condition, SpecifyBetween 0 and 0 *When 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, SpecifyBetween 0 and 0 *If 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, SpecifyBetween 0 and 0 *The 3D SCANNER, 3D MiniLift or 3D Lift, and Automatic Leveling Platform must be stored in an indoor air-conditioned location.
Special Storage Condition, SpecifyBetween 0 and 0 *To maintain mechanical integrity, do not store water in the Water Tank. Ensure that the system is clean and dry before storing.
Special Storage Condition, SpecifyBetween 0 and 0 *Before 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, SpecifyBetween 0 and 0 *If 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, SpecifyBetween 0 and 0 *For 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, SpecifyBetween 0 and 0 *Store 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, SpecifyBetween 0 and 0 *Two person lift required. Use proper lifting and handling techniques to prevent injury or equipment damage. Lift the Water Tank using the four lift handles.
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments.
Special Storage Condition, SpecifyBetween 0 and 0 *Do 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, SpecifyBetween 0 and 0 *Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Never 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, SpecifyBetween 0 and 0 *When 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.
Special Storage Condition, SpecifyBetween 0 and 0 *When 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, SpecifyBetween 0 and 0 *If 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, SpecifyBetween 0 and 0 *The 3D SCANNER, 3D MiniLift or 3D Lift, and Automatic Leveling Platform must be stored in an indoor air-conditioned location.
Special Storage Condition, SpecifyBetween 0 and 0 *To maintain mechanical integrity, do not store water in the Water Tank. Ensure that the system is clean and dry before storing.
Special Storage Condition, SpecifyBetween 0 and 0 *Before 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, SpecifyBetween 0 and 0 *If 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, SpecifyBetween 0 and 0 *For 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, SpecifyBetween 0 and 0 *Store 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, SpecifyBetween 0 and 0 *Two person lift required. Use proper lifting and handling techniques to prevent injury or equipment damage. Lift the Water Tank using the four lift handles.
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments.
Special Storage Condition, SpecifyBetween 0 and 0 *Do 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, SpecifyBetween 0 and 0 *Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB01612300000TZ0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-14

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