StereoPHAN 1255000-0Z

GUDID 05060608880102

Radiation therapy, machine QA device

SUN NUCLEAR CORP.

Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device

• Primary Device ID: 05060608880102
• NIH Device Record Key: b596e112-9866-418b-9c22-58b90f039215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StereoPHAN
• Version Model Number: 1255300
• Catalog Number: 1255000-0Z
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
• Storage Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880102 [Primary]

FDA Product Code

• IXG: Phantom, Anthropomorphic, Radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-31
• Device Publish Date: 2020-07-23

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: 2020-07-31Radiation therapy, machine QA device
• 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.