EPIgray EP1001

GUDID B501EPIGRAY020010

Radiotherapy quality assurance software tool.

DOSISOFT

Radiation therapy software

• Primary Device ID: B501EPIGRAY020010
• NIH Device Record Key: 0193b8ce-b377-48cf-b1fe-dc3957b6001b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIgray
• Version Model Number: 2.0.10
• Catalog Number: EP1001
• 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	B501EPIGRAY020010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112723

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2023-07-10
• Device Publish Date: 2023-06-30

On-Brand Devices [EPIgray]

• B501EPIGRAY020006: Radiotherapy software quality assurance tool.
• B501EPIGRAY020010: Radiotherapy quality assurance software tool.