3D SCANNER (TNC) 12300000TZ

GUDID B01612300000TZ0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device Accelerator system quality assurance device

• Primary Device ID: B01612300000TZ0
• NIH Device Record Key: 98a3193f-eeb6-45b0-b856-c3d82fb60a4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D SCANNER (TNC)
• Version Model Number: 12300000TZ
• Catalog Number: 12300000TZ
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments.
• Special Storage Condition, Specify: Between 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, Specify: Between 0 and 0 *Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room.
• Special Storage Condition, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments.
• Special Storage Condition, Specify: Between 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, Specify: Between 0 and 0 *Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01612300000TZ0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101992

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-14

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