IC PROFILER-MR 1122000-0MRZ

GUDID 05060608880768

Radiation therapy 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 ID05060608880768
NIH Device Record Key417193dc-95bb-490a-b219-366d68761e9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIC PROFILER-MR
Version Model Number1123300Z
Catalog Number1122000-0MRZ
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 0 and 0 *CAUTION: Do not store IC PROFILER-MR where the electronics can be accidentally irradiated by the direct beam.
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]
GS105060608880768 [Primary]

FDA Product Code

LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

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