Daily QA-MR 1093000-0MRZ

GUDID 05060608880959

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 ID: 05060608880959
• NIH Device Record Key: ed99fab0-c2f7-47ac-9898-3e1ec1f3c8d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Daily QA-MR
• Version Model Number: 1096300Z
• Catalog Number: 1093000-0MRZ
• 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

• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room
• Special Storage Condition, Specify: Between 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected 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 *To minimize damage to electronics, do not store the device in the treatment room

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880959 [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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