3D SCANNER TPR Option 12300004Z

GUDID B01612300004Z0

Accessory to the 1230 3D SCANNER.

SUN NUCLEAR CORP.

Accelerator system quality assurance device Accelerator system quality assurance device

• Primary Device ID: B01612300004Z0
• NIH Device Record Key: 7745924d-bdd5-4773-bd14-7e5cdcbfadd1
• Commercial Distribution Discontinuation: 2019-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 3D SCANNER TPR Option
• Version Model Number: 12300004Z
• Catalog Number: 12300004Z
• 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

• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880300 [Primary]
HIBCC	B01612300004Z0 [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: 5
• Public Version Date: 2019-06-18
• Device Publish Date: 2017-01-14

Devices Manufactured by SUN NUCLEAR CORP.

• 05060608881178 - Precision Cut EBT3 GafChromic™ Film: 2024-01-10 Precision Cut EBT3 GafChromic™ Film
• 05060608881123 - SunSCAN 3D: 2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
• 05060608881130 - SunSCAN 3D: 2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
• 05060608880041 - rf-IVD 2: 2020-08-03 Radiation therapy QA device.
• 05060608880874 - PlanIQ: 2020-08-03 Radiation therapy QA software.
• 05060608880102 - StereoPHAN: 2020-07-31 Radiation therapy, machine QA device
• 05060608880751 - IC PROFILER: 2020-07-31 Radiation therapy QA device.
• 05060608880768 - IC PROFILER-MR: 2020-07-31 Radiation therapy QA device.