Daily QA-MR 1093000-0MRZ

GUDID 05060608880959

Radiation therapy QA device.

SUN NUCLEAR CORP.

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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