IC PROFILER-MR 1122000-0MRZ

GUDID 05060608880768

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608880768
• NIH Device Record Key: 417193dc-95bb-490a-b219-366d68761e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IC PROFILER-MR
• Version Model Number: 1123300Z
• Catalog Number: 1122000-0MRZ
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
• Special Storage Condition, Specify: Between 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *When storing or transporting the IC PROFILER-MR, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
• Special Storage Condition, Specify: Between 0 and 0 *If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
• Special Storage Condition, Specify: Between 0 and 0 *Whether storing or shipping the IC PROFILER-MR, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
• Special Storage Condition, Specify: Between 0 and 0 *If IC PROFILER-MR is not stored at treatment room temperature, allow the device to reach temperature equilibrium before acquiring measurements.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880768 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

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

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