ThinkQA, EPIbeam 1.0.2

GUDID B501THINKQA010002

Radiation therapy quality assurance and error detection software suite

DOSISOFT

Radiation therapy software

• Primary Device ID: B501THINKQA010002
• NIH Device Record Key: b559b0d8-8518-44a0-b034-d4ea763e1d3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinkQA, EPIbeam
• Version Model Number: 1.0.2
• Catalog Number: 1.0.2
• Company DUNS: 264815932
• Company Name: DOSISOFT
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B501THINKQA010002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180106

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: 2018-04-18

On-Brand Devices [ThinkQA, EPIbeam]

• B501THINKQA010002: Radiation therapy quality assurance and error detection software suite
• B501THINKQA010006: Radiation therapy quality assurance and error detection software suite.