ThinkQA Edition 2 TK2010, TK2020

GUDID B501THINKQA0200010

Secondary Dose Check for external beam radiation therapy.

DOSISOFT

Radiation therapy software

• Primary Device ID: B501THINKQA0200010
• NIH Device Record Key: 40848cc6-4042-4975-ba64-3267fb5ae0b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinkQA Edition 2
• Version Model Number: 2.0.1
• Catalog Number: TK2010, TK2020
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B501THINKQA0200010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231573

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: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [ThinkQA Edition 2]

• B501THINKQA0200010: Secondary Dose Check for external beam radiation therapy.
• B501THINKQA0200000: Secondary Dose Check for external beam radiation therapy.
• B501THINKQA0200020: Secondary Dose Check for external beam radiation therapy.