ArcCHECK-MR 12200000MR

GUDID B01612200000MR0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: B01612200000MR0
• NIH Device Record Key: 5e33dad6-08f1-4c19-9a7e-839506f38291
• Commercial Distribution Discontinuation: 2019-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ArcCHECK-MR
• Version Model Number: 12200000MR
• Catalog Number: 12200000MR
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.
• Special Storage Condition, Specify: Between 0 and 0 *When the ArcCHECK arrives at its destination, store it for 24 to 48 hours in a climate-controlled environment that meets the Storage Specifications.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01612200000MR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160057

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-18
• Device Publish Date: 2017-01-14

On-Brand Devices [ArcCHECK-MR]

• B01612200000MR0: Radiation therapy QA device.
• 05060608880355: Radiation therapy QA device.