SRS MapCHECK 11790000Z

GUDID B01611790000Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: B01611790000Z0
• NIH Device Record Key: 3b0fa1d4-625c-4edf-bc04-5c08b1bfaee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SRS MapCHECK
• Version Model Number: 11790000Z
• Catalog Number: 11790000Z
• 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.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01611790000Z0 [Primary]

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-31

On-Brand Devices [SRS MapCHECK]

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