System 2100

GUDID B229S210011

MATH RESOLUTIONS, LLC

Radiation therapy software

• Primary Device ID: B229S210011
• NIH Device Record Key: e018eb57-3ecd-4bd1-a408-8576c0faf470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System 2100
• Version Model Number: 1
• Company DUNS: 021888258
• Company Name: MATH RESOLUTIONS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B229S210011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993530

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-17

Devices Manufactured by MATH RESOLUTIONS, LLC

• B229DC041 - Dosimetry Check: 2018-07-06
• B229DC051 - Dosimetry Check: 2018-07-06
• B229MC11 - MillComp: 2018-07-06
• B229MRT21 - MarkRT: 2018-07-06
• B229RTDP21 - RtDosePlan: 2018-07-06
• B229S210011 - System 2100: 2018-07-06
• B229S210011 - System 2100: 2018-07-06