SRS MapCHECK 1179000-0Z

GUDID 05060608880188

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: 05060608880188
• NIH Device Record Key: ec1b0272-b579-49fa-abcd-cda48e803036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SRS MapCHECK
• Version Model Number: 1179300Z
• Catalog Number: 1179000-0Z
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument 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 *Do not store the instrument in the treatment room.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880188 [Primary]
HIBCC	B01611790000Z0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131466

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2020-07-30
• Device Publish Date: 2020-07-22

On-Brand Devices [SRS MapCHECK]

• B01611790000Z0: Radiation therapy QA device.
• 05060608880188: Radiation therapy QA device.